Identity
- Trade Name
- FIXIT FDA UDI
- Generic Name
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
- Device Name
- Threaded anchor system for rotator cuff repair - CLASSIC - Ø 4.7 mm FDA UDI
- Model / Reference
- FIXIT Threaded anchor system FDA UDI
- Description
- Threaded anchor system for rotator cuff repair - CLASSIC - Ø 4.7 mm FDA UDI
Identifiers
- Catalog Number
- EPA0047CLA FDA UDI
- Primary DI / UDI-DI
- 03760154008846 FDA UDI
- 510(k) Number
- K170868 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
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
Yes
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4.7 Millimeter FDA UDI
Category: Tendon/ligament bone anchor, bioabsorbable
Fixit by S.b.m — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tendon/ligament bone anchor, bioabsorbable.
- Arthrex® — Arthrex, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- HEALIX PEEK ORTHOCORD — Medos International Sàrl · Class II
- Arthrex® — Arthrex, Inc. · Class II
- 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
K170868 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
- S.b.m
Sources (1)
- FDA UDI 972e8d34-0d22-4bbd-80f6-b24a5660a8c7 37 fields · synced May 30, 2026