← Back to catalogue
Ibs™
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref S22 ST011Ref G01 00131Ref G01 01311Ref S27 ST016Ref S27 ST012Ref G01 00421Ref S27 ST020Ref G01 00371Ref G01 01291Ref G01 00141Ref G01 01352Ref G01 00331Ref S22 ST009Ref S27 ST013Ref G01 00091Ref G01 00241Ref S22 ST012Ref S27 ST014Ref G01 00732Ref G01 01341Ref G01 00852Ref G01 01251Ref G01 00731Ref G01 00171Ref G01 01361Ref S22 ST013
by In2Bones SAS
Identity
- Trade Name
- IBS™ EUDAMEDFDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDIOrthopaedic bone screw (non-sliding) FDA UDISurgical screwdriver, reusable FDA UDISurgical drill guide, reusable FDA UDICannulated surgical drill bit, single-use FDA UDIOrthopaedic bone screw starter/notcher FDA UDISurgical depth gauge, reusable FDA UDI
- Device Name
- IBS 2.2-S SNAP-OFF SCREW EUDAMEDI.B.S®-C Compression and I.B.S®-N Neutralization osteosynthesis Instruments EUDAMEDInstruments, orthopaedic surgeries of the upper and lower extremities EUDAMEDPERCUTANEOUS BURRS EUDAMED2IN1 DRILL DIAM 1.6 LG18 MM AO NO STERILE CANNULATED LG65 MM FDA UDIIBS 2.2-S SNAP-OFF SCREW DIAM 2.2 MM LG12 MM FDA UDIIBS 2.2-S SNAP-OFF SCREW DIAM 2.2 MM LG13 MM FDA UDICANNULATED POWER TIP TORX8 FOR 1.0 MM K-WIRE FDA UDI2IN1 DRILL DIAM 5.5/7.0 LG130 NO STERILE CANNULATED 2.5 MM FDA UDIDRILL DIAM 3.0 MM AO ATTACHMENT CANNULATED NS LG110 MM FDA UDIEXTERNAL PROTECTION SLEEVE FOR SCREW DIAM 8.0 MM FDA UDIINTERNAL PROTECTION SLEEVE FOR KWIRE 2.0 MM FDA UDICANNULATED SCREWDRIVER T7-L MEASURING FUNCTION FDA UDIIBS 2.2-S SNAP-OFF SCREW DIAM 2.2 MM LG11 MM FDA UDI2IN1 DRILL DIAM 2.2 LG32 MM AO STERILE CANNULATED LG65 MM FDA UDIFOREFOOT STARTER FOR SCREW STEPPED PROFILE FDA UDIIBS 2.7-S SNAP-OFF SCREW DIAM 2.7 MM LG16 MM FDA UDI150 MM KWIRE MEASURER DIAM 1.6 MM FDA UDIINTERNAL PROTECTION SLEEVE FOR KWIRE 2.5 MM FDA UDIT30 SCREWDRIVER TIP CANNULATED KWIRE 2.5 MM FDA UDIIBS 2.7-S SNAP-OFF SCREW DIAM 2.7 MM LG14 MM FDA UDIT15 SCREWDRIVER CANNULATED KWIRE 1.6 MM FDA UDIIBS 2.7-S SNAP-OFF SCREW DIAM 2.7 MM LG13 MM FDA UDIIBS 2.2-S SNAP-OFF SCREW DIAM 2.2 MM LG09 MM FDA UDIT30 SCREWDRIVER CANNULATED KWIRE 2.5 MM FDA UDIIBS 2.7-S SNAP-OFF SCREW DIAM 2.7 MM LG20 MM FDA UDI2IN1 DRILL DIAM 1.6 LG26 MM AO STERILE CANULATED LG65 MM FDA UDIDRILL DIAM 5.5 MM LG20 MM NO STERILE CANNULATED 2.5 MM FDA UDIIBS 2.7-S SNAP-OFF SCREW DIAM 2.7 MM LG12 MM FDA UDI2IN1 DRILL DIAM 2.2 LG32 MM AO NO STERILE CANNULATED LG65 MM FDA UDI
- Model / Reference
- S22 ST011 EUDAMEDFDA UDIG01 00131 EUDAMEDFDA UDIG01 01311 EUDAMEDFDA UDIS27 ST016 EUDAMEDFDA UDIS27 ST012 EUDAMEDFDA UDIG01 00421 EUDAMEDFDA UDIS27 ST020 EUDAMEDFDA UDIG01 00371 EUDAMEDFDA UDIG01 01291 EUDAMEDFDA UDIG01 00141 EUDAMEDFDA UDIG01 01352 EUDAMEDFDA UDIG01 00331 EUDAMEDFDA UDIS22 ST009 EUDAMEDFDA UDIS27 ST013 EUDAMEDFDA UDIG01 00091 EUDAMEDFDA UDIG01 00241 EUDAMEDFDA UDIS22 ST012 EUDAMEDFDA UDIS27 ST014 EUDAMEDFDA UDIG01 00732 EUDAMEDFDA UDIG01 01341 EUDAMEDFDA UDIG01 00852 EUDAMEDFDA UDIG01 01251 EUDAMEDFDA UDIG01 00731 EUDAMEDFDA UDIG01 00171 EUDAMEDFDA UDIG01 01361 EUDAMEDFDA UDIS22 ST013 EUDAMEDFDA UDI
- Description
- 2IN1 DRILL DIAM 1.6 LG18 MM AO NO STERILE CANNULATED LG65 MM FDA UDIIBS 2.2-S SNAP-OFF SCREW DIAM 2.2 MM LG12 MM FDA UDIIBS 2.2-S SNAP-OFF SCREW DIAM 2.2 MM LG13 MM FDA UDICANNULATED POWER TIP TORX8 FOR 1.0 MM K-WIRE FDA UDI2IN1 DRILL DIAM 5.5/7.0 LG130 NO STERILE CANNULATED 2.5 MM FDA UDIDRILL DIAM 3.0 MM AO ATTACHMENT CANNULATED NS LG110 MM FDA UDIEXTERNAL PROTECTION SLEEVE FOR SCREW DIAM 8.0 MM FDA UDIINTERNAL PROTECTION SLEEVE FOR KWIRE 2.0 MM FDA UDICANNULATED SCREWDRIVER T7-L MEASURING FUNCTION FDA UDIIBS 2.2-S SNAP-OFF SCREW DIAM 2.2 MM LG11 MM FDA UDI2IN1 DRILL DIAM 2.2 LG32 MM AO STERILE CANNULATED LG65 MM FDA UDIFOREFOOT STARTER FOR SCREW STEPPED PROFILE FDA UDIIBS 2.7-S SNAP-OFF SCREW DIAM 2.7 MM LG16 MM FDA UDI150 MM KWIRE MEASURER DIAM 1.6 MM FDA UDIINTERNAL PROTECTION SLEEVE FOR KWIRE 2.5 MM FDA UDIT30 SCREWDRIVER TIP CANNULATED KWIRE 2.5 MM FDA UDIIBS 2.7-S SNAP-OFF SCREW DIAM 2.7 MM LG14 MM FDA UDIT15 SCREWDRIVER CANNULATED KWIRE 1.6 MM FDA UDIIBS 2.7-S SNAP-OFF SCREW DIAM 2.7 MM LG13 MM FDA UDIIBS 2.2-S SNAP-OFF SCREW DIAM 2.2 MM LG09 MM FDA UDIT30 SCREWDRIVER CANNULATED KWIRE 2.5 MM FDA UDIIBS 2.7-S SNAP-OFF SCREW DIAM 2.7 MM LG20 MM FDA UDI2IN1 DRILL DIAM 1.6 LG26 MM AO STERILE CANULATED LG65 MM FDA UDIDRILL DIAM 5.5 MM LG20 MM NO STERILE CANNULATED 2.5 MM FDA UDIIBS 2.7-S SNAP-OFF SCREW DIAM 2.7 MM LG12 MM FDA UDI2IN1 DRILL DIAM 2.2 LG32 MM AO NO STERILE CANNULATED LG65 MM FDA UDI
Identifiers
- Catalog Number
- G01 01352 FDA UDIS22 ST012 FDA UDIS22 ST013 FDA UDIG01 00241 FDA UDIG01 00141 FDA UDIG01 00091 FDA UDIG01 01311 FDA UDIG01 01251 FDA UDIG01 00852 FDA UDIS22 ST011 FDA UDIG01 00731 FDA UDIG01 01341 FDA UDIS27 ST016 FDA UDIG01 00171 FDA UDIG01 01291 FDA UDIG01 00371 FDA UDIS27 ST014 FDA UDIG01 00331 FDA UDIS27 ST013 FDA UDIS22 ST009 FDA UDIG01 00421 FDA UDIS27 ST020 FDA UDIG01 01361 FDA UDIG01 00131 FDA UDIS27 ST012 FDA UDIG01 00732 FDA UDI
- Primary DI / UDI-DI
- 03760225710050 EUDAMEDFDA UDI03760225714232 EUDAMEDFDA UDI03760225714300 EUDAMEDFDA UDI03760225712610 EUDAMEDFDA UDI03760225712238 EUDAMEDFDA UDI03760225714263 EUDAMEDFDA UDI03760225712634 EUDAMEDFDA UDI03760225714256 EUDAMEDFDA UDI03760225714287 EUDAMEDFDA UDI03760225714249 EUDAMEDFDA UDI03760225714485 EUDAMEDFDA UDI03760225713112 EUDAMEDFDA UDI03760225712597 EUDAMEDFDA UDI03760225712245 EUDAMEDFDA UDI03760225713105 EUDAMEDFDA UDI03760225712146 EUDAMEDFDA UDI03760225710067 EUDAMEDFDA UDI03760225712252 EUDAMEDFDA UDI03760225712542 EUDAMEDFDA UDI03760225710487 EUDAMEDFDA UDI03760225710968 EUDAMEDFDA UDI03760225713181 EUDAMEDFDA UDI03760225713020 EUDAMEDFDA UDI03760225713136 EUDAMEDFDA UDI03760225712535 EUDAMEDFDA UDI03760225710074 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760225710050 EUDAMEDB-03760225714232 EUDAMED37013376411674 EUDAMEDB-03760225712610 EUDAMEDB-03760225712238 EUDAMED3701337640997V EUDAMEDB-03760225712634 EUDAMEDB-03760225714256 EUDAMEDB-03760225714249 EUDAMEDB-03760225714485 EUDAMED3701337641146Y EUDAMEDB-03760225712597 EUDAMEDB-03760225712245 EUDAMEDB-03760225713105 EUDAMEDB-03760225712146 EUDAMEDB-03760225710067 EUDAMEDB-03760225712252 EUDAMEDB-03760225712542 EUDAMEDB-03760225710487 EUDAMEDB-03760225713020 EUDAMED3701337641026R EUDAMEDB-03760225712535 EUDAMEDB-03760225710074 EUDAMED
- 510(k) Number
- K132911 FDA UDI
- FDA Product Code
- GFG FDA UDIHWC FDA UDIHXX FDA UDIFZX FDA UDIHWD FDA UDIFTY FDA UDI
- EMDN Code
- P09120603 CANNULATED SCREWS EUDAMEDL091002 INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMEDL26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMEDL091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMEDP091303 ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE EUDAMEDL0923 ORTHOPAEDICS SURGICAL MEASURERS, REUSABLE EUDAMED
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDIOrthopaedic bone screw (non-sliding) FDA UDISurgical screwdriver, reusable FDA UDISurgical drill guide, reusable FDA UDICannulated surgical drill bit, single-use FDA UDIOrthopaedic bone screw starter/notcher FDA UDISurgical depth gauge, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass IIa EUDAMEDClass I EUDAMEDFDA UDIClass II FDA UDI
- Regulation Number
- 878.4820 FDA UDI888.3040 FDA UDI888.4540 FDA UDI878.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
No
FDA UDIFDA UDI
Implantable
Yes
EUDAMEDFDA UDIEUDAMEDFDA UDI
Reusable
No
EUDAMEDEUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDIFDA UDI
Lot / Batch Number
No
FDA UDIFDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDIFDA UDI
Manufacturing Date
Yes
FDA UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2.2 Millimeter FDA UDILength — 12 Millimeter FDA UDILength — 13 Millimeter FDA UDILength — 11 Millimeter FDA UDILength — 16 Millimeter FDA UDIOuter Diameter — 2.7 Millimeter FDA UDILength — 14 Millimeter FDA UDILength — 9 Millimeter FDA UDILength — 20 Millimeter FDA UDI
Ibs™ by In2Bones SAS — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-03760225710050 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-03760225710050 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- In2Bones SAS
- EUDAMED SRN
- FR-MF-000005246
Sources (78)
- EUDAMED 256f0861-ce1f-4134-a9f0-e90d9c6934c3 61 fields · synced Jul 30, 2026
- EUDAMED 0cc28237-eea2-47c7-bf2c-27fadc3337a7 61 fields · synced May 11, 2026
- EUDAMED 151a12dc-59b0-42cf-8bdb-b99473cfe6b5 61 fields · synced May 11, 2026
- EUDAMED 1a203b96-0c67-459a-ade6-f2c13de21952 61 fields · synced May 11, 2026
- EUDAMED 77aa6f3b-f242-4ad0-9683-6d3c40e85ad9 61 fields · synced May 16, 2026
- EUDAMED f7ee9491-aa12-4bc6-ad0f-f4fbdb03f425 61 fields · synced May 16, 2026
- EUDAMED e1782fd2-89ba-4a78-aabe-4c65d4bb3044 61 fields · synced May 16, 2026
- EUDAMED 4122ad81-2241-41ca-a4c5-7723a874efa3 61 fields · synced May 17, 2026
- EUDAMED 0abf60fe-c628-46ca-9756-3a2acccb0ce6 61 fields · synced May 17, 2026
- EUDAMED 241a0020-e807-4783-b07e-503e75f2084b 61 fields · synced May 17, 2026
- EUDAMED 4a74b7bc-08a7-4e4b-97c2-d4a657fae803 61 fields · synced May 17, 2026
- EUDAMED 0da7797d-a6ee-46af-a2a4-a72b2cda7ee9 61 fields · synced May 17, 2026
- EUDAMED 1e9e074b-54dd-4489-bd7b-8c8891594062 61 fields · synced May 17, 2026
- EUDAMED 03403306-4a10-4d8a-a7c8-3625314404ca 61 fields · synced May 17, 2026
- EUDAMED c7e28bc5-c2a6-4d82-9fc0-edff68631884 61 fields · synced May 17, 2026
- EUDAMED 0fb455e6-1bdd-42c8-9345-514defb35d37 61 fields · synced May 17, 2026
- EUDAMED f563666e-72be-4168-9ab5-f2e46f4f7dab 61 fields · synced May 17, 2026
- EUDAMED 2cbf34ce-d5fb-472d-aeb6-84ac300e2069 61 fields · synced May 17, 2026
- EUDAMED 0948c6ba-fa08-4c05-a059-d57ebae8a426 61 fields · synced May 18, 2026
- EUDAMED 3f5138c7-3929-4d47-abfa-369ae60d4cf7 61 fields · synced May 18, 2026
- EUDAMED 92619bf4-6be9-49d8-b8b1-1e6f4f93d59a 61 fields · synced May 18, 2026
- EUDAMED 7ac0bfb0-7e10-40b7-b999-c8085c38b428 61 fields · synced May 18, 2026
- EUDAMED cbe0f08a-f0d6-4eec-9b21-e79389b9dbb5 61 fields · synced May 18, 2026
- EUDAMED f23ae359-8977-4d60-956b-13e1c26497a3 61 fields · synced May 19, 2026
- EUDAMED c8eac674-0046-4eda-a38e-4cd09250203d 61 fields · synced May 19, 2026
- EUDAMED 6ac47c54-2bf5-48de-845f-0da0dfca865a 61 fields · synced May 19, 2026
- FDA UDI 167a208f-736c-40b1-8562-6a222d07ecf0 35 fields · synced May 29, 2026
- FDA UDI a8a4ea21-2ebf-429a-b820-0ffce9adbdd2 37 fields · synced May 29, 2026
- FDA UDI f8af43db-eb5e-4da5-ad7a-745decae6cb1 37 fields · synced May 29, 2026
- FDA UDI 28603286-37dc-481a-9248-35c267a28f7d 35 fields · synced May 29, 2026
- FDA UDI 7f70dd90-e1fe-4e35-b876-f7620e5ee5f0 35 fields · synced May 29, 2026
- FDA UDI f1e136da-d198-4e19-bfc7-4cd9ec82838c 35 fields · synced May 30, 2026
- FDA UDI 4b3c0788-a5be-4661-acba-03cecfec82d8 35 fields · synced May 30, 2026
- FDA UDI 5d61b247-3d53-44ab-ab64-126d66135e80 35 fields · synced May 30, 2026
- FDA UDI fd85dd7a-b121-49eb-b236-ba528d8dd79b 35 fields · synced May 30, 2026
- FDA UDI 6850eb62-77b2-494e-ad34-44fd3cb67192 37 fields · synced May 30, 2026
- FDA UDI a89d1668-e34b-4092-b05d-cc914b2efe98 35 fields · synced May 30, 2026
- FDA UDI c245f0f4-4f51-4121-87d4-41df9546c881 35 fields · synced May 30, 2026
- FDA UDI 9556071c-e03f-4337-8179-443b98332eb4 37 fields · synced May 30, 2026
- FDA UDI eec4c115-7507-4efc-a28e-14018e803674 35 fields · synced May 30, 2026
- FDA UDI eb2de38d-d401-4d33-863d-b4e254506796 35 fields · synced May 30, 2026
- FDA UDI 665e9a99-f50e-4e81-b71b-b2ed45d8f8e9 35 fields · synced May 30, 2026
- FDA UDI f246c11d-e99a-4e6f-a8fe-ce64cbf1db5c 37 fields · synced May 30, 2026
- FDA UDI 992f47ca-b600-44a3-990d-22b56f0832b6 35 fields · synced May 30, 2026
- FDA UDI df4c52c8-83ef-49a8-928b-2652626bf1e2 37 fields · synced May 30, 2026
- FDA UDI 9f713c75-5f13-41ae-a906-cd69c050edb0 37 fields · synced May 30, 2026
- FDA UDI 592ead5a-0d4b-4fcb-aec7-6829e0111b8c 35 fields · synced May 30, 2026
- FDA UDI 1d1ea092-b5a4-448b-abd2-33f29f7e6652 37 fields · synced May 30, 2026
- FDA UDI a1cbf589-863e-4457-85e1-7eecb591af25 35 fields · synced May 30, 2026
- FDA UDI 416603dc-c3da-40f3-97de-70ce9ef59a6f 35 fields · synced May 30, 2026
- FDA UDI 9508ea4f-8af8-49b8-85ca-0fd860d22b4b 37 fields · synced May 30, 2026
- FDA UDI 7135ee10-7536-4cf8-9e75-27095f01e761 35 fields · synced May 30, 2026
- EUDAMED 6cb0a6c1-ad66-4503-b998-03ebb9a42879 61 fields · synced Jul 8, 2026
- EUDAMED 0d648da7-2cbd-4db3-9b31-a2a2e638811d 61 fields · synced Jul 9, 2026
- EUDAMED 6648de02-df0e-4155-ae8b-091ea893d56d 61 fields · synced Jul 10, 2026
- EUDAMED ca96beb2-f637-40ab-a6b7-7bb40237e0c4 61 fields · synced Jul 10, 2026
- EUDAMED 31011adc-de87-4e5c-98dc-6e2189b65369 61 fields · synced Jul 12, 2026
- EUDAMED 6e00b420-f071-4ef4-ab61-974e3041a6ab 61 fields · synced Jul 12, 2026
- EUDAMED 09fc644a-1863-4b30-ba27-5b6257619fed 61 fields · synced Jul 12, 2026
- EUDAMED 67831d80-a37e-454d-b83f-55c2ef686391 61 fields · synced Jul 12, 2026
- EUDAMED d29bbf48-9302-4716-aef2-771a476e2010 61 fields · synced Jul 14, 2026
- EUDAMED 6b73162c-02ff-4a09-8e4b-3d69e2128cdf 61 fields · synced Jul 17, 2026
- EUDAMED 5aca65ef-6341-48fa-9ec8-ffa5f29b1d2a 61 fields · synced Jul 17, 2026
- EUDAMED 8462faa6-54ce-436d-b669-92ff18c5d3e9 61 fields · synced Jul 19, 2026
- EUDAMED 1d1fbb6c-5b8b-49a4-9ac0-1077aec78659 61 fields · synced Jul 19, 2026
- EUDAMED 63c621f2-bd51-4f57-98e1-09f6427baf28 61 fields · synced Jul 19, 2026
- EUDAMED 85386738-eb70-4e3b-a54b-43b84630bace 61 fields · synced Jul 21, 2026
- EUDAMED c9654eb1-9de9-40ea-ae8c-a73eed8605b9 61 fields · synced Jul 21, 2026
- EUDAMED a908a545-bffd-4bcb-8d40-2b1f191d495f 61 fields · synced Jul 23, 2026
- EUDAMED b5cf0610-2f7d-4dac-8f11-1746b81e8dc4 61 fields · synced Jul 24, 2026
- EUDAMED 30819b31-bc99-454e-bedb-6b04cab714ff 61 fields · synced Jul 24, 2026
- EUDAMED 835213e0-5f55-4ee2-bdbd-4ac44a44bf24 61 fields · synced Jul 24, 2026
- EUDAMED 41c92294-0000-40b0-9241-f7804cd47f78 61 fields · synced Jul 24, 2026
- EUDAMED 0f304993-bd30-4cbb-a219-4b5e1e795629 61 fields · synced Jul 25, 2026
- EUDAMED a3782cec-293a-4927-892d-5d3d43d9bd8b 61 fields · synced Jul 25, 2026
- EUDAMED 52b32ae3-e2d0-48a1-9b17-df1ef1fde90c 61 fields · synced Jul 29, 2026
- EUDAMED 1cc7e804-3c56-4046-bcc2-2a34271b9af9 61 fields · synced Jul 30, 2026
- EUDAMED 168d7410-1b8c-4a91-995e-b1ba049e8786 61 fields · synced Jul 30, 2026