Identity
- Trade Name
- CHS FDA UDI
- Generic Name
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
- Device Name
- TIP THREADED GUIDE PIN 279.4MM FDA UDI
- Model / Reference
- 128194 FDA UDI
- Description
- TIP THREADED GUIDE PIN 279.4MM FDA UDI
Identifiers
- Catalog Number
- 128194 FDA UDI
- Primary DI / UDI-DI
- 03596010083265 FDA UDI
- 510(k) Number
- K123055 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone pin, non-bioabsorbable
Chs 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 pin, non-bioabsorbable.
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- XtraFix® External Fixation System — Zimmer, Inc. · Class II
- CALIBRATED GUIDE WIRE, THREADED TROCAR POINT — Biomet Orthopedics, Inc. · Class II
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- KW02-300-20.A — newbox medical GmbH · Class IIb
Cleared under the same submission
K123055 also covers:
- BIRMINGHAM HIP RESURFACING(BHR) — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- Cannulated Screws — Smith & Nephew, Inc.
- Cannulated Screws — Smith & Nephew, Inc.
- Cannulated Screws — Smith & Nephew, Inc.
- Cannulated Screws — Smith & Nephew, Inc.
- Jet-X — Smith & Nephew, Inc.
- LARGE CANNULATED SCREWS — Smith & Nephew, Inc.
- LARGE CANNULATED SCREWS — Smith & Nephew, Inc.
- LARGE CANNULATED SCREWS — Smith & Nephew, Inc.
- LEGION — Smith & Nephew, Inc.
- LEGION — 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 e9681f91-a30d-4ca0-a181-ab9737ea1fe8 36 fields · synced Jun 8, 2026