Identity
- Trade Name
- FairFix Adjustable Button System FDA UDI
- Generic Name
- Soft-tissue/mesh anchor, non-bioabsorbable FDA UDI
- Device Name
- FairFix Adjustable Button Extender FDA UDI
- Model / Reference
- 05.05.0092 FDA UDI
- Description
- FairFix Adjustable Button Extender FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630345703934 FDA UDI
- 510(k) Number
- K203259 FDA UDI
- FDA Product Code
- MBI FDA UDI
- GMDN Term
- Soft-tissue/mesh anchor, 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
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: Soft-tissue/mesh anchor, non-bioabsorbable
FairFix Adjustable Button System by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Soft-tissue/mesh anchor, non-bioabsorbable.
- HNM MEDICAL — HNM STAINLESS, LLC. · Class II
- Anchorsure — DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL · Class II
- FiberStitch™ Implant, Reverse Curve with two Polyester Implants and 2-0 FiberWir — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class II
- Heli-FX™ Thoracic EndoAnchor™ System — MEDTRONIC VASCULAR, INC. · Class II
- JUGGERSTITCH™ — Biomet Orthopedics, Inc. · Class II
- JuggerStitch® — Biomet Orthopedics, Inc. · Class II
- Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC. · Class II
- Lateral Suture Anchor, PEEK 6.5mm x 20mm — BIOPRO, INC. · Class II
Cleared under the same submission
K203259 also covers:
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
- Medacta International
Sources (1)
- FDA UDI a629c7aa-ca8e-4fc3-8947-6fd4051dc26d 34 fields · synced May 30, 2026