Identity
- Trade Name
- Sklar® FDA UDI
- Generic Name
- Orthopaedic bone wire FDA UDI
- Device Name
- K-WIRE 2 TROCAR ENDS 9"X.035 FDA UDI
- Model / Reference
- 40-1580 FDA UDI
- Description
- K-WIRE 2 TROCAR ENDS 9"X.035 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10649111081521 FDA UDI
- 510(k) Number
- K083912 FDA UDI
- FDA Product Code
- HTY FDA UDI
- GMDN Term
- Orthopaedic bone wire 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic bone wire
Sklar® by Sklar Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K083912 also covers:
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
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
- Sklar Corporation
Sources (1)
- FDA UDI e25e19b3-f0c0-4410-833d-5f586a49ac52 34 fields · synced Jun 6, 2026