Identity
- Trade Name
- Steinmann Pins, K-Wire, smooth FDA UDI
- Generic Name
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
- Model / Reference
- SP001.101.024.K4 FDA UDI
Identifiers
- Catalog Number
- SP001.101.024 FDA UDI
- Primary DI / UDI-DI
- 14053613159644 FDA UDI
- 510(k) Number
- K131264 FDA UDI
- FDA Product Code
- HTY FDA UDI
- GMDN Term
- Orthopaedic bone pin, non-bioabsorbable 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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone pin, non-bioabsorbable
Steinmann Pins, K-Wire, smooth by Gebr. Brasseler GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone pin, non-bioabsorbable.
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- SMART TSF — Smith & Nephew, Inc. · Class II
- KW02-300-20.A — newbox medical GmbH · Class IIb
- SMART TSF — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K131264 also covers:
- GUIDE PIN SET — Gebr. Brasseler GmbH & Co. KG
- GUIDE PIN/SCREW — Gebr. Brasseler GmbH & Co. KG
- GUIDE PIN/SCREW — Gebr. Brasseler GmbH & Co. KG
- GUIDE PIN/SCREW — Gebr. Brasseler GmbH & Co. KG
- GUIDE PIN/SCREW — Gebr. Brasseler GmbH & Co. KG
- GUIDE PIN/SCREW — Gebr. Brasseler GmbH & Co. KG
- GUIDE PIN/SCREW — Gebr. Brasseler GmbH & Co. KG
- GUIDE PIN/SCREW — Gebr. Brasseler GmbH & Co. KG
- Guide Pin — Gebr. Brasseler GmbH & Co. KG
- Guide Pin & Guide Screw Kit — Gebr. Brasseler GmbH & Co. KG
- Guide Pin Fluted — Gebr. Brasseler GmbH & Co. KG
- Guide Pin Set — Gebr. Brasseler GmbH & Co. KG
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
- Gebr. Brasseler GmbH & Co. KG
Sources (1)
- FDA UDI 4294866f-a0b7-4d3e-8436-ede12934793d 34 fields · synced May 30, 2026