Identity
- Trade Name
- SUMMIT FDA UDI
- Generic Name
- Orthopaedic implant driver FDA UDI
- Device Name
- SUMMIT FIXATION SYSTEM MINI POLY OUTER NUT TIGHTENER FDA UDI
- Model / Reference
- 274641100 FDA UDI
- Description
- SUMMIT FIXATION SYSTEM MINI POLY OUTER NUT TIGHTENER FDA UDI
Identifiers
- Catalog Number
- 274641100 FDA UDI
- Primary DI / UDI-DI
- 10705034192925 FDA UDI
- FDA Product Code
- HWR FDA UDI
- GMDN Term
- Orthopaedic implant driver FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Summit by Depuy Spine, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Depuy Spine, Inc.
Sources (1)
- FDA UDI 6e2be254-e10a-49bd-90bc-9b667e3d7696 36 fields · synced Jun 1, 2026