Identity
- Trade Name
- X-Wing Tensioner EUDAMEDFDA UDI
- Generic Name
- Orthopaedic graft tensioner, reusable FDA UDI
- Device Name
- Ligament Tensioner - Measuring EUDAMEDIntended to be used for the preparation and pre-tensioning of single tendon grafts for ligament reconstruction FDA UDI
- Model / Reference
- 72205271 EUDAMEDFDA UDI
- Description
- Intended to be used for the preparation and pre-tensioning of single tendon grafts for ligament reconstruction FDA UDI
Identifiers
- Catalog Number
- 72205271 FDA UDI
- Primary DI / UDI-DI
- 09421028113458 EUDAMEDFDA UDI
- Basic UDI-DI
- 942102811GMN00182C EUDAMED
- Direct Marketing DI
- 09421028113458 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091106 INSTRUMENTS FOR THE PREPARATION OF TISSUE IMPLANTS IN ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic graft tensioner, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic graft tensioner, reusable
X-Wing Tensioner by Enztec Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic graft tensioner, reusable.
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- TABLE TENSIONER — Biomet Orthopedics, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- BIOSURE — Smith & Nephew, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Enztec Limited
Sources (2)
- FDA UDI 9eb0221a-0cb2-42c6-8aee-840a4bf0d02b 34 fields · synced Jul 18, 2026
- EUDAMED 14416871-e485-4e82-8c6e-51c1aa5df360 61 fields · synced Jul 18, 2026