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Pit'stop®
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref M02 00011Ref M02 00071Ref M20 SP011Ref M02 00101Ref M20 SP012Ref M02 00091Ref M02 00051Ref M02 00081
by In2Bones SAS
Identity
- Trade Name
- PIT'STOP® EUDAMEDFDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDIBone lever/elevator, reusable FDA UDISurgical implant/trial-implant/sizer holder, reusable FDA UDIOrthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- PIT’STOP® INSTRUMENTS EUDAMEDPIT'STOP SUBTALAR IMPLANT EUDAMEDInstruments, orthopaedic surgeries of the upper and lower extremities EUDAMEDPIT'STOP TRIAL IMPLANT SIZE 17 MM FDA UDIPIT'STOP VILADOT'S PALANCA FDA UDIPIT'STOP INTERNAL HOLDER FDA UDIPIT'STOP TRIAL IMPLANT SIZE 10 MM FDA UDIPIT'STOP SUBTALAR IMPLANT PEEK SIZE 11MM STERILE FDA UDIPIT'STOP TRIAL IMPLANT SIZE 14 MM FDA UDIPIT'STOP EXTERNAL HOLDER FDA UDIPIT'STOP SUBTALAR IMPLANT PEEK SIZE 12MM STERILE FDA UDI
- Model / Reference
- M02 00011 EUDAMEDFDA UDIM02 00071 EUDAMEDFDA UDIM20 SP011 EUDAMEDFDA UDIM02 00101 EUDAMEDFDA UDIM20 SP012 EUDAMEDFDA UDIM02 00091 EUDAMEDFDA UDIM02 00051 EUDAMEDFDA UDIM02 00081 EUDAMEDFDA UDI
- Description
- PIT'STOP TRIAL IMPLANT SIZE 17 MM FDA UDIPIT'STOP VILADOT'S PALANCA FDA UDIPIT'STOP INTERNAL HOLDER FDA UDIPIT'STOP TRIAL IMPLANT SIZE 10 MM FDA UDIPIT'STOP SUBTALAR IMPLANT PEEK SIZE 11MM STERILE FDA UDIPIT'STOP TRIAL IMPLANT SIZE 14 MM FDA UDIPIT'STOP EXTERNAL HOLDER FDA UDIPIT'STOP SUBTALAR IMPLANT PEEK SIZE 12MM STERILE FDA UDI
Identifiers
- Catalog Number
- M02 00071 FDA UDIM02 00081 FDA UDIM02 00101 FDA UDIM02 00011 FDA UDIM20 SP011 FDA UDIM02 00051 FDA UDIM02 00091 FDA UDIM20 SP012 FDA UDI
- Primary DI / UDI-DI
- 03760225713204 EUDAMEDFDA UDI03760225713266 EUDAMEDFDA UDI03760225713341 EUDAMEDFDA UDI03760225713297 EUDAMEDFDA UDI03760225713358 EUDAMEDFDA UDI03760225713280 EUDAMEDFDA UDI03760225713242 EUDAMEDFDA UDI03760225713273 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760225713204 EUDAMEDB-03760225713266 EUDAMEDB-03760225713341 EUDAMED3701337641006M EUDAMEDB-03760225713358 EUDAMEDB-03760225713242 EUDAMED3701337641036T EUDAMED
- 510(k) Number
- K170688 FDA UDI
- FDA Product Code
- HWT FDA UDIKIL FDA UDIHWA FDA UDIHWC FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMEDP090605 FOOT ENDORTHESIS EUDAMED
- GMDN Term
- Surgical implant template, reusable FDA UDIBone lever/elevator, reusable FDA UDISurgical implant/trial-implant/sizer holder, reusable FDA UDIOrthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass IIb EUDAMEDClass I EUDAMEDFDA UDIClass II FDA UDI
- Regulation Number
- 888.4800 FDA UDI888.4540 FDA UDI888.3040 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
No
FDA UDIFDA UDI
Implantable
No
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
EUDAMED
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
Dimensions & Sizes
- Size
- Width — 16.5 Millimeter FDA UDILength — 18 Millimeter FDA UDIWidth — 9.5 Millimeter FDA UDILength — 12.7 Millimeter FDA UDIWidth — 11 Millimeter FDA UDILength — 13.3 Millimeter FDA UDIWidth — 13.5 Millimeter FDA UDILength — 15.9 Millimeter FDA UDILength — 14.4 Millimeter FDA UDIWidth — 12 Millimeter FDA UDI
Pit'stop® by In2Bones SAS — Class IIa — 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-03760225713204 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-03760225713204 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- In2Bones SAS
- EUDAMED SRN
- FR-MF-000005246
Sources (23)
- EUDAMED 7c6a6c3b-d3ca-424b-9778-addaa48f240a 61 fields · synced Jul 31, 2026
- EUDAMED 28a6f6b4-753e-4c9a-a251-f431868117e9 61 fields · synced May 17, 2026
- EUDAMED b4ab3a88-614f-4828-9a8a-d0ba62cc8526 61 fields · synced May 17, 2026
- EUDAMED 154d48c9-5486-4f6e-bf47-33e32b27a70c 61 fields · synced May 18, 2026
- EUDAMED 1c8f622d-d2d9-40f7-8d05-8ae70ce99085 61 fields · synced May 18, 2026
- EUDAMED 424415ff-1979-4edc-8ae0-ee9d2be9b9a9 61 fields · synced May 18, 2026
- EUDAMED 1167b36e-eb4a-47cc-af86-86f12b75c0ad 61 fields · synced May 18, 2026
- EUDAMED 2dcae9b8-c6fc-42dd-ae2c-a65d1e134d6d 61 fields · synced May 18, 2026
- FDA UDI 6353e610-876b-4aa1-9f50-daea6f7810f0 36 fields · synced May 29, 2026
- FDA UDI 80197a55-d2c0-40df-ad84-a193f28c36a8 35 fields · synced May 30, 2026
- FDA UDI 2c4801fc-0ffb-4913-bb38-f6f7317e8584 35 fields · synced May 30, 2026
- FDA UDI 65a2d83c-d6e6-4623-b0a5-fbfc9d8b49f8 36 fields · synced May 30, 2026
- FDA UDI 4bfcb87c-b760-4ef9-90c4-505b5e05b36b 37 fields · synced May 30, 2026
- FDA UDI 50f9ff8b-47cb-4a71-8e3c-111344843b58 36 fields · synced May 30, 2026
- FDA UDI f506b970-5d39-49f6-b196-814249f93537 35 fields · synced May 30, 2026
- FDA UDI a2e9f1bc-5819-4c18-90ef-4368ee81c2f1 37 fields · synced May 30, 2026
- EUDAMED e654c73c-ae45-4f26-baa7-5dbbdc579e34 61 fields · synced Jul 20, 2026
- EUDAMED b1d53b82-737b-419d-be0a-e1ce6688d535 61 fields · synced Jul 23, 2026
- EUDAMED a237fa77-55fa-4b29-8709-f2c51f13ea1f 61 fields · synced Jul 23, 2026
- EUDAMED f5ba1330-de33-4fbe-a9c7-5ed9f55ce223 61 fields · synced Jul 24, 2026
- EUDAMED 84ed0549-da01-4031-88cb-29c31b91f10d 61 fields · synced Jul 25, 2026
- EUDAMED 3e61423e-3712-4716-b61d-86bed6892bb1 61 fields · synced Jul 26, 2026
- EUDAMED 9c21d4d8-7f3d-4bde-8b74-edd3dff9a303 61 fields · synced Jul 31, 2026