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WasherCap™ Fixation System 8mm
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref ABWC0821Model 21
Identity
- Trade Name
- WasherCap™ Fixation System 8mm EUDAMEDFDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Device Name
- WasherCap™ Fixation System 8mm 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 UDIABWC0821 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
- 08437019739829 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08437019739829 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 8mm by Abanza Tecnomed, S.l. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-08437019739829 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Abanza Tecnomed, S.l.
- EUDAMED SRN
- ES-MF-000007530
Sources (2)
- EUDAMED 53dc22e4-b68e-44ce-8a6b-1e5bbad7f77b 61 fields · synced Jul 15, 2026
- FDA UDI 6272ce6f-afc9-4d64-8d7b-ea83299ee6ac 36 fields · synced May 30, 2026