Identity
- Trade Name
- FAST-FIX FDA UDI
- Generic Name
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
- Device Name
- ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT FDA UDI
- Model / Reference
- 72201493 FDA UDI
- Description
- ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT FDA UDI
Identifiers
- Catalog Number
- 72201493 FDA UDI
- Primary DI / UDI-DI
- 03596010610911 FDA UDI
- 510(k) Number
- K151105 FDA UDI
- FDA Product Code
- GAT FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tendon/ligament bone anchor, bioabsorbable
Fast-Fix by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tendon/ligament bone anchor, bioabsorbable.
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- 5 x 15mm CitreLock Implant — ACUITIVE TECHNOLOGIES · Class II
- Fix2Lock — OSTEONIC CO., Ltd. · Class II
- Fixone Hybrid Anchor — AJU PHARM. CO., LTD. · Class II
- RIGIDFIX BIOCRYL — Medos International Sàrl · Class II
Cleared under the same submission
K151105 also covers:
- BIORAPTOR / ULTRABRAID — Smith & Nephew, Inc.
- BIORAPTOR / ULTRABRAID — Smith & Nephew, Inc.
- BIORAPTOR / ULTRABRAID — Smith & Nephew, Inc.
- BIORAPTOR/ULTRABRAID — Smith & Nephew, Inc.
- BIORAPTOR/ULTRABRAID — Smith & Nephew, Inc.
- BIORAPTOR/ULTRABRAID — Smith & Nephew, Inc.
- FAST-FIX — Smith & Nephew, Inc.
- FAST-FIX — Smith & Nephew, Inc.
- HEALICOIL — Smith & Nephew, Inc.
- HEALICOIL — Smith & Nephew, Inc.
- HEALICOIL — Smith & Nephew, Inc.
- HEALICOIL — 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 874b5a7d-dc1f-42e1-ae0e-7d7d9c829547 36 fields · synced Jun 8, 2026