Identity
- Trade Name
- LARGE CANNULATED SCREWS FDA UDI
- Generic Name
- Orthopaedic bone washer, sterile FDA UDI
- Device Name
- TITANIUM WASHER-12.7MM OUTER DIAMETER 6.5MM INNER DIAMETER FDA UDI
- Model / Reference
- 71102000 FDA UDI
- Description
- TITANIUM WASHER-12.7MM OUTER DIAMETER 6.5MM INNER DIAMETER FDA UDI
Identifiers
- Catalog Number
- 71102000 FDA UDI
- Primary DI / UDI-DI
- 03596010291127 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone washer, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic bone washer, sterile
Large Cannulated Screws by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone washer, sterile.
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Cleared under the same submission
K210837 also covers:
- CHS — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- D-RAD SMART PACK — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 548ba3f9-05d6-45bf-8493-185786f5420f 36 fields · synced Jun 8, 2026