X-Wing Base
- Primary DI
- 09421028113441
- Brand
- X-Wing Base
- Company
- ENZTEC LIMITED
- Model
- 72205270
- Catalog number
- 72205270
- Device description
- Intended to be used for the preparation and pre-tensioning of single tendon grafts for ligament reconstruction.
- Published
- 2020-11-30
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| LXH | Orthopedic Manual Surgical Instrument |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 09421028113441 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 09421028113441 | 09421028113441 | 9421028113441 |
GMDN Terms
| Term | Definition |
|---|---|
| Orthopaedic graft tensioner, reusable | A hand-held, manual surgical instrument intended to be used during an open-surgery procedure [e.g., acromioclavicular joint repair, anterior cruciate ligament (ACL) reconstruction] to apply appropriate tension to a ligament graft/prosthesis, or flexible cord, to remove slack and facilitate adequate positioning of the device during implantation; it may also be used to apply tension to flexible instruments used during the procedure (e.g., graft sizer or gauge). Tension is applied to the graft after one end of the graft has been secured. The device is typically made of metal and in the form of a shaft with distal prongs. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 592616445
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
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|---|---|---|---|---|
| 09421038412220 | Enztec XR Trinket M8X1.0-01 | 4252-2449 | 4252-2449 | 2026-03-13 |
| 09421038412145 | Cup reamer handle, offset, Z/H, locking | 9209-1301 | 9209-1301 | 2026-03-09 |
| 09421038412152 | Offset coupling, Z/H | 9209-1306 | 9209-1306 | 2026-03-09 |
| 09421038412169 | Offset drive train, locking | 9209-1303 | 9209-1303 | 2026-03-09 |
| 09421038412176 | Short Offset Cover – United | 9209-1307 | 9209-1307 | 2026-03-09 |
| 09421038412183 | Handle – United | 9209-1305 | 9209-1305 | 2026-03-09 |
| 09421038412299 | Cup reamer handle, offset, AO, locking | 9209-1311 | 9209-1311 | 2026-03-09 |
| 09421038412305 | Offset coupling, AO | 9209-1313 | 9209-1313 | 2026-03-09 |
| 09421038412312 | Cup reamer handle, offset, AO, open | 9209-1312 | 9209-1312 | 2026-03-09 |
| 09421038412329 | Offset drive train, open | 9209-1304 | 9209-1304 | 2026-03-09 |
| 09421038412671 | Cup reamer handle, offset, Z/H, open | 9209-1302 | 9209-1302 | 2026-03-09 |
| 09421038411865 | Enztec Modular OCI X | 4251-3101 | 4251-3101 | 2026-02-27 |
| 09421038411889 | Adj Dist Fem Alignment Guide – Cartilage | 4240-7700 | 4240-7700 | 2026-02-27 |
| 09421038411896 | Adj Dist Fem Alignment Guide – Paddle | 4240-7701 | 4240-7701 | 2026-02-27 |
| 09421038411902 | Sagittal Alignment Connector - Pivot | 4240-7705 | 4240-7705 | 2026-02-27 |
| 09421038411919 | Sagittal Alignment Connector - Pivot with Fan | 4240-7706 | 4240-7706 | 2026-02-27 |
| 09421038411926 | Dist Fem Cut Block Connector – 8mm | 4240-7710 | 4240-7710 | 2026-02-27 |
| 09421038411933 | Dist Fem Cut Block Connector – 9mm | 4240-7711 | 4240-7711 | 2026-02-27 |
| 09421038411940 | Dist Fem Cut Block Connector – 10mm | 4240-7712 | 4240-7712 | 2026-02-27 |
| 09421038411957 | Dist Fem Cut Block Slot Connector – 8mm | 4240-7725 | 4240-7725 | 2026-02-27 |
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