Identity
- Trade Name
- TWINFIX/DURABRAID FDA UDI
- Generic Name
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
- Device Name
- TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB FDA UDI
- Model / Reference
- 72200786 FDA UDI
- Description
- TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB FDA UDI
Identifiers
- Catalog Number
- 72200786 FDA UDI
- Primary DI / UDI-DI
- 03596010579355 FDA UDI
- 510(k) Number
- K151105 FDA UDI
- FDA Product Code
- MAI FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, 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
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
Yes
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
Twinfix/Durabraid 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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- 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.
- FAST-FIX — 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 43b9da7a-5c0b-4583-b6d3-4598c430d1c5 36 fields · synced Jun 8, 2026