Identity
- Trade Name
- iFix® Interference Screw FDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Model / Reference
- CM-1925 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887868269592 FDA UDI
- 510(k) Number
- K073426 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Tendon/ligament bone 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: Tendon/ligament bone anchor, non-bioabsorbable
iFix® Interference Screw by Cayenne Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tendon/ligament bone anchor, non-bioabsorbable.
- Hi-Fi — Conmed Corporation · Class II
- FLIPTIGHT LOOP — RIVERPOINT MEDICAL LLC · Class II
- Ecobone — Bonegraft Biomaterials Co. · Class III
- fX — Bonegraft Biomaterials Co. · Class III
- GII PANACRYL — DePuy Mitek, Inc. · Class II
- Power Button Adjustable Loop — RIVERPOINT MEDICAL LLC · Class II
- SignaLoc Screw — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- JuggerKnot Soft Anchors — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K073426 also covers:
- iFix® — CAYENNE MEDICAL, INC.
- iFix® — CAYENNE MEDICAL, INC.
- iFix® — CAYENNE MEDICAL, INC.
- iFix® — CAYENNE MEDICAL, INC.
- iFix® — CAYENNE MEDICAL, INC.
- iFix® — CAYENNE MEDICAL, INC.
- iFix® — CAYENNE MEDICAL, INC.
- iFix® — CAYENNE MEDICAL, INC.
- iFix® — CAYENNE MEDICAL, INC.
- iFix® — CAYENNE MEDICAL, INC.
- iFix® — CAYENNE MEDICAL, INC.
- iFix® — CAYENNE MEDICAL, 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
- Cayenne Medical, Inc.
Sources (1)
- FDA UDI 3764b6e5-bbb3-4723-8fbb-3ac3ca08b76c 33 fields · synced Jun 1, 2026