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Neofit
EUDAMEDFDA UDIClass I (EU MDR)
Ref P01 00321Ref P01 00381Ref P01 00311Ref P01 00281Ref P01 00371Ref P01 00291Ref P01 00271Ref P10 ST150Ref P10 ST235Ref P01 00251Ref P01 00301Ref P10 ST145
by In2Bones SAS
Identity
- Trade Name
- NEOFIT EUDAMEDFDA UDI
- Generic Name
- Surgical vice, bench FDA UDISurgical drill guide, reusable FDA UDIOrthopaedic fixation plate, non-bioabsorbable FDA UDISurgical implant template, reusable FDA UDIFluted surgical drill bit, reusable FDA UDI
- Device Name
- Instruments, orthopaedic surgeries of the upper and lower extremities EUDAMEDNEOFIT MTP PLATING SYSTEM EUDAMEDNEOFIT MTP PLATE EUDAMEDNEOFIT PLATE BENDER LEFT FDA UDINEOFIT DRILL GUIDE OBLONG - RIGHT FDA UDINEOFIT MTP PLATE RIGHT STERILE SIZE 1 - 40 MM FDA UDINEOFIT PLATE BENDER RIGHT FDA UDINEOFIT TRIAL PLATE SIZE 45 MM FDA UDINEOFIT TRIAL PLATE SIZE 35 MM FDA UDINEOFIT MTP PLATE RIGHT STERILE SIZE 2- 45 MM FDA UDIDRILL DIAM 2.0 MM NEOFIT FDA UDINEOFIT MODULAR DRILL GUIDE STD DIAM 2.0 MM FDA UDINEOFIT MTP PLATE LEFT STERILE SIZE 3 - 50 MM FDA UDINEOFIT DRILL GUIDE STD DIAM 2.0 MM FDA UDINEOFIT DRILL GUIDE OBLONG - LEFT FDA UDI
- Model / Reference
- P01 00321 EUDAMEDFDA UDIP01 00381 EUDAMEDFDA UDIP01 00311 EUDAMEDFDA UDIP01 00281 EUDAMEDFDA UDIP01 00371 EUDAMEDFDA UDIP01 00291 EUDAMEDFDA UDIP01 00271 EUDAMEDFDA UDIP10 ST150 EUDAMEDP10 ST235 EUDAMEDP01 00251 EUDAMEDFDA UDIP01 00301 EUDAMEDFDA UDIP10 ST145 EUDAMEDFDA UDIP10 ST140 FDA UDIP10 ST250 FDA UDI
- Description
- NEOFIT PLATE BENDER LEFT FDA UDINEOFIT DRILL GUIDE OBLONG - RIGHT FDA UDINEOFIT MTP PLATE RIGHT STERILE SIZE 1 - 40 MM FDA UDINEOFIT PLATE BENDER RIGHT FDA UDINEOFIT TRIAL PLATE SIZE 45 MM FDA UDINEOFIT TRIAL PLATE SIZE 35 MM FDA UDINEOFIT MTP PLATE RIGHT STERILE SIZE 2- 45 MM FDA UDIDRILL DIAM 2.0 MM NEOFIT FDA UDINEOFIT MODULAR DRILL GUIDE STD DIAM 2.0 MM FDA UDINEOFIT MTP PLATE LEFT STERILE SIZE 3 - 50 MM FDA UDINEOFIT DRILL GUIDE STD DIAM 2.0 MM FDA UDINEOFIT DRILL GUIDE OBLONG - LEFT FDA UDI
Identifiers
- Catalog Number
- P01 00311 FDA UDIP01 00281 FDA UDIP10 ST140 FDA UDIP01 00321 FDA UDIP01 00251 FDA UDIP01 00371 FDA UDIP10 ST145 FDA UDIP01 00381 FDA UDIP01 00301 FDA UDIP10 ST250 FDA UDIP01 00271 FDA UDIP01 00291 FDA UDI
- Primary DI / UDI-DI
- 03760225714201 EUDAMEDFDA UDI03760225716144 EUDAMEDFDA UDI03760225714195 EUDAMEDFDA UDI03760225714164 EUDAMEDFDA UDI03760225716151 EUDAMEDFDA UDI03760225714171 EUDAMEDFDA UDI03760225714157 EUDAMEDFDA UDI03760225712924 EUDAMEDFDA UDI03760225712962 EUDAMEDFDA UDI03760225714133 EUDAMEDFDA UDI03760225714188 EUDAMEDFDA UDI03760225712917 EUDAMEDFDA UDI
- Basic UDI-DI
- 3701337641236Z EUDAMEDB-03760225716144 EUDAMED37013376410773 EUDAMEDB-03760225716151 EUDAMEDB-03760225712924 EUDAMEDB-03760225712962 EUDAMEDB-03760225714133 EUDAMEDB-03760225712917 EUDAMED
- 510(k) Number
- K160995 FDA UDI
- FDA Product Code
- HXW FDA UDIFZX FDA UDIHRS FDA UDIHWT FDA UDIGFG FDA UDI
- EMDN Code
- L091002 INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMEDP09120599 BONE FIXATION PLATES - OTHER EUDAMED
- GMDN Term
- Surgical vice, bench FDA UDISurgical drill guide, reusable FDA UDIOrthopaedic fixation plate, non-bioabsorbable FDA UDISurgical implant template, reusable FDA UDIFluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIa EUDAMEDClass IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.4540 FDA UDI878.4800 FDA UDI888.3030 FDA UDI888.4800 FDA UDI878.4820 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDINot in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
No
FDA UDIFDA UDI
Implantable
No
EUDAMEDFDA UDIEUDAMEDFDA UDI
Reusable
Yes
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
Yes
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
No
FDA UDIFDA UDI
Lot / Batch Number
Yes
FDA 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
MR Conditional FDA UDI
Neofit by In2Bones SAS — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 3701337641236Z | Class I | Active |
| EUDAMED | European Union | CE/MDR | 3701337641236Z | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- In2Bones SAS
- EUDAMED SRN
- FR-MF-000005246
Sources (36)
- EUDAMED f27696df-b2c8-4cff-b57d-cbe6e5a40260 61 fields · synced Aug 4, 2026
- EUDAMED 09027de0-b4e7-4a77-b9e8-6f58725a5f20 61 fields · synced May 16, 2026
- EUDAMED b97fd117-f170-4ea7-9508-e1437662359a 61 fields · synced May 17, 2026
- EUDAMED ced08e7a-dda7-4301-b2aa-89fb3202837a 61 fields · synced May 17, 2026
- EUDAMED 13a4b6c2-73f6-4099-a9c0-7f5939c72639 61 fields · synced May 17, 2026
- EUDAMED 32d2002b-459d-4fdf-9f5d-a84e1a5686fa 61 fields · synced May 17, 2026
- EUDAMED 68e5f680-5bc8-406a-983a-d12660b5ea7c 61 fields · synced May 18, 2026
- EUDAMED 63cf4c76-094a-4f45-8da8-89ba53ec517d 61 fields · synced May 18, 2026
- EUDAMED 1bc01c0b-7a10-4807-be09-467470a5a920 61 fields · synced May 18, 2026
- EUDAMED 9d312453-3ed6-4b25-a142-bcf49c937147 61 fields · synced May 18, 2026
- EUDAMED ae77b4b9-acd1-477d-b4f3-2141b8a0559f 61 fields · synced May 18, 2026
- EUDAMED 8f0a00c7-8018-4c63-9760-c4fc8e0b0c74 61 fields · synced May 18, 2026
- FDA UDI 723530a1-2644-4d78-aaab-577ab8dc5d13 35 fields · synced May 29, 2026
- FDA UDI 3c7d156c-ca57-413f-b567-41955278c32a 35 fields · synced May 30, 2026
- FDA UDI ad47af1b-707e-4c30-a6ef-f482bb9f54da 37 fields · synced May 30, 2026
- FDA UDI 101f64c3-80e4-4842-b7b1-51dc6f781902 35 fields · synced May 30, 2026
- FDA UDI 8be8f55f-d9f5-4397-8c5e-7d349448e737 36 fields · synced May 30, 2026
- FDA UDI 7b1337a5-51d4-4db6-8b36-65e51a662c6e 36 fields · synced May 30, 2026
- FDA UDI c0b8ee67-7bde-4d10-8cfa-135204f66bb1 37 fields · synced May 30, 2026
- FDA UDI 80c45e42-4763-4221-9110-6b8862083a9e 36 fields · synced May 30, 2026
- FDA UDI e774c1d9-6a2d-482b-896b-73e32156a870 35 fields · synced May 30, 2026
- FDA UDI 6e519fce-1ea0-480a-bcff-3c087d393a42 37 fields · synced May 30, 2026
- FDA UDI b6e848c0-c4c5-4f22-85f3-a098701b3241 35 fields · synced May 30, 2026
- FDA UDI 17d0ca0b-f023-4f53-b1db-d571afbe83be 35 fields · synced May 30, 2026
- EUDAMED afa7c508-fd65-406a-a720-f3eabd8e1453 61 fields · synced Jun 20, 2026
- EUDAMED c284e75a-a246-4b1a-aea2-e3ebdc7bcc4f 61 fields · synced Jul 12, 2026
- EUDAMED d3aa3815-d901-44f2-97c5-f87c706db32b 61 fields · synced Jul 13, 2026
- EUDAMED 4a4a3b57-f693-49d0-b20e-de940c0713e0 61 fields · synced Jul 13, 2026
- EUDAMED df5cb186-b49a-4e73-ad54-5ff065bccc86 61 fields · synced Jul 15, 2026
- EUDAMED 8f9fa6f3-a138-463d-8efb-aae82e934f78 61 fields · synced Jul 17, 2026
- EUDAMED d12a38da-8644-44a9-9468-a5db353f8a93 61 fields · synced Jul 17, 2026
- EUDAMED d51f6ee8-2b51-49d6-83e3-ef3c5f0b99d1 61 fields · synced Jul 20, 2026
- EUDAMED f318fd99-abbe-4f24-9a6a-083902a02a12 61 fields · synced Jul 28, 2026
- EUDAMED 0a7c5c84-1b5c-466d-944b-584ba5cf8734 61 fields · synced Aug 2, 2026
- EUDAMED 588da572-2870-4734-975f-96c4f5e52efe 61 fields · synced Aug 3, 2026
- EUDAMED 47ef3f9f-9340-4fe6-9cd5-1e9114325b07 61 fields · synced Aug 4, 2026