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WasherCap™ Fixation System 10mm
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref ABWC1021Model 21
Identity
- Trade Name
- WasherCap™ Fixation System 10mm EUDAMEDFDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Device Name
- WasherCap™ Fixation System 10mm EUDAMEDWasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue grafts, including tendons and ligaments, during surgical procedures such as in Anterior Cruciate Ligament (ACL) reconstruction of the knee. FDA UDI
- Model / Reference
- 21 EUDAMEDFDA UDIABWC1021 EUDAMED
- Description
- WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue grafts, including tendons and ligaments, during surgical procedures such as in Anterior Cruciate Ligament (ACL) reconstruction of the knee. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08437019739843 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08437019739843 EUDAMED
- 510(k) Number
- K212197 FDA UDI
- FDA Product Code
- MBI FDA UDI
- EMDN Code
- P09120699 BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER 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
- Spain 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 Safe FDA UDI
WasherCap™ Fixation System 10mm by Abanza Tecnomed, S.l. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250238 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K212197 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08437019739843 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Abanza Tecnomed, S.l.
- EUDAMED SRN
- ES-MF-000007530
Sources (3)
- EUDAMED 6a0a6d3d-c6b6-4b57-95ea-420c0fecc642 61 fields · synced Jul 31, 2026
- FDA UDI 47c8dd95-aa4a-4e30-8221-ab8c29447264 36 fields · synced May 29, 2026
- FDA 510(k) K250238 1 fields · synced May 18, 2026