Identity
- Trade Name
- PIT'STOP® EUDAMEDFDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- PIT'STOP SUBTALAR IMPLANT EUDAMEDPIT'STOP SUBTALAR IMPLANT PEEK SIZE 17MM STERILE FDA UDI
- Model / Reference
- M20 SP017 EUDAMEDFDA UDI
- Description
- PIT'STOP SUBTALAR IMPLANT PEEK SIZE 17MM STERILE FDA UDI
Identifiers
- Catalog Number
- M20 SP017 FDA UDI
- Primary DI / UDI-DI
- 03760225713396 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760225713396 EUDAMED
- 510(k) Number
- K170688 FDA UDI
- FDA Product Code
- HWC FDA UDI
- EMDN Code
- P090605 FOOT ENDORTHESIS EUDAMED
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
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 UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 18 Millimeter FDA UDIWidth — 17 Millimeter FDA UDI
Pit'stop® by In2Bones SAS — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760225713396 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- In2Bones SAS
- EUDAMED SRN
- FR-MF-000005246
Sources (2)
- EUDAMED 3d5dddce-670b-4263-97a7-cf5d237eb126 61 fields · synced Jun 8, 2026
- FDA UDI 6afcf427-45e4-4ea5-8506-c73f6778c428 37 fields · synced May 30, 2026