Identity
- Trade Name
- Broach Set SPX1 FDA UDI
- Generic Name
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
- Model / Reference
- A00021 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701311500032 FDA UDI
- 510(k) Number
- K202547 FDA UDI
- FDA Product Code
- OXO FDA UDIJAA FDA UDIOWB FDA UDI
- GMDN Term
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Broach Set SPX1 by Ecential Robotics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K202547 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ecential Robotics
Sources (1)
- FDA UDI 8f025c2a-9b42-46fc-9407-7c072656f983 35 fields · synced May 30, 2026