Identity
- Trade Name
- CROSSFT, HI-FI EUDAMEDFDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Device Name
- Orthopedic, Implant, Non-absorbable, Suture Anchor, PEEK, Shoulder, CrossFT Knotless EUDAMEDCrossFT Knotless 5.5 mm Suture Anchor with one 2 mm Hi-Fi Tape (Blue) FDA UDI
- Model / Reference
- CFK-55STA EUDAMEDFDA UDI
- Description
- CrossFT Knotless 5.5 mm Suture Anchor with one 2 mm Hi-Fi Tape (Blue) FDA UDI
Identifiers
- Catalog Number
- CFK-55STA FDA UDI
- Primary DI / UDI-DI
- 10845854044643 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10845854044643 EUDAMED
- 510(k) Number
- K163258 FDA UDI
- FDA Product Code
- MBI FDA UDI
- EMDN Code
- P09120102 ANCHORS, TENDON AND LIGAMENT SYNTHESIS EUDAMED
- GMDN Term
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: Hand-held surgical retractor, reusable
Crossft, Hi-Fi by Conmed Corporation — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10845854044643 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED e019fb24-fc94-4fcd-8efc-1034ce4c3528 61 fields · synced May 31, 2026
- FDA UDI b1518aa0-0d57-455a-827e-596f771768e6 38 fields · synced May 29, 2026