Identity
- Trade Name
- K-Wire, 1.6mm x 100mm Long FDA UDI
- Generic Name
- Orthopaedic intraoperative positioning pin, single-use FDA UDI
- Device Name
- K-Wire, 1.6mm x 100mm Long FDA UDI
- Model / Reference
- KW1600 FDA UDI
- Description
- K-Wire, 1.6mm x 100mm Long FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810054091585 FDA UDI
- 510(k) Number
- K211592 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDI
- GMDN Term
- Orthopaedic intraoperative positioning pin, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic intraoperative positioning pin, single-use
K-Wire, 1.6mm x 100mm Long by Avanti Orthopaedics Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic intraoperative positioning pin, single-use.
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Cleared under the same submission
K211592 also covers:
- Block (CS00 Sub-Component) — AVANTI ORTHOPAEDICS LLC
- Block Screw (CS00 Sub-Component) — AVANTI ORTHOPAEDICS LLC
- Bone Clamp Ulnar Shortening — AVANTI ORTHOPAEDICS LLC
- Compression Sled Assembly — AVANTI ORTHOPAEDICS LLC
- Cutting Guide Screw — AVANTI ORTHOPAEDICS LLC
- Cutting Guide, 2mm — AVANTI ORTHOPAEDICS LLC
- Cutting Guide, 3mm — AVANTI ORTHOPAEDICS LLC
- Cutting Guide, 4mm — AVANTI ORTHOPAEDICS LLC
- Cutting Guide, 5mm — AVANTI ORTHOPAEDICS LLC
- Cutting Guide, 6mm — AVANTI ORTHOPAEDICS LLC
- Cutting Guide, 7mm — AVANTI ORTHOPAEDICS LLC
- Jacking Screw (CS00 Sub-Component) — AVANTI ORTHOPAEDICS LLC
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
- Avanti Orthopaedics Llc
Sources (1)
- FDA UDI ef14d008-acb1-477a-b95c-aa97542e34c7 35 fields · synced May 30, 2026