Identity
- Trade Name
- GUARDSMAN EUDAMEDFDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Device Name
- Orthopedic, Implant, Non-absorbable, Interference Screw, Titanium, Knee, Cannulated EUDAMEDGUARDSMAN FEMORAL INTERFERENCE SCREW 7 MM X 25 MM FDA UDI
- Model / Reference
- C8325 EUDAMEDFDA UDI
- Description
- GUARDSMAN FEMORAL INTERFERENCE SCREW 7 MM X 25 MM FDA UDI
Identifiers
- Catalog Number
- C8325 FDA UDI
- Primary DI / UDI-DI
- 20845854014148 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20845854014148 EUDAMED
- 510(k) Number
- K874676 FDA UDI
- FDA Product Code
- HWC FDA UDI
- EMDN Code
- P09120605 INTERFERENCE SCREWS 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 25 Millimeter FDA UDIOuter Diameter — 7 Millimeter FDA UDI
Category: Tendon/ligament bone anchor, non-bioabsorbable
Guardsman by Conmed Corporation — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tendon/ligament bone anchor, non-bioabsorbable.
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- SignaLoc Screw — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- JuggerKnot Soft Anchors — Biomet Orthopedics, Inc. · Class II
- OrthoButton AL — RIVERPOINT MEDICAL LLC · Class II
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-20845854014148 | 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 e3e78be1-daab-422e-a001-261002c55d2c 61 fields · synced Jun 8, 2026
- FDA UDI d89ad725-b5ab-4154-ae87-47c84da2418c 38 fields · synced May 29, 2026