TLX
TLX Implant, 16x13x31mm 20°
1manufacturer
88catalogue numbers in this listing
Who Else Makes It
Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
Record
| Listed by | Nuvasive, Inc., United States |
|---|---|
| FDA product code | PHM |
| Device type | Intervertebral Fusion Device With Bone Graft, Thoracic |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K171633 |
| Record published | 2019-12-06 |
| Record revised | 2025-07-14 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5895836P2 | In distribution | |
| 5895041P2 | In distribution | |
| 1792698 | In distribution | |
| 5894126P2 | In distribution | |
| 1792648 | In distribution | |
| 5800713 | In distribution | |
| 5906026 | In distribution | |
| 1792617 | In distribution | |
| 5905636P2 | In distribution | |
| 5894426P2 | In distribution | |
| 5906031 | In distribution | |
| 5902826P2 | In distribution | |
| 5902327P2 | In distribution | |
| 5902427P2 | In distribution | |
| 5896741P2 | In distribution | |
| 1792651 | In distribution | |
| 1792611 | In distribution | |
| 1792696 | In distribution | |
| 5894927P2 | In distribution | |
| 1792637 | In distribution | |
| 1792647 | In distribution | |
| 5902026P2 | In distribution | |
| 5894526P2 | In distribution | |
| 1930150 | In distribution | |
| 1792603 | In distribution | |
| 5902926P2 | In distribution | |
| 5906000 | In distribution | |
| 5905536P2 | In distribution | |
| 5902226P2 | In distribution | |
| 1792621 | In distribution | |
| 1792638 | In distribution | |
| 5902526P2 | In distribution | |
| 5903141P2 | In distribution | |
| 5894427P2 | In distribution | |
| 1792673 | In distribution | |
| 1792678 | In distribution | |
| 5895641P2 | In distribution | |
| 1792628 | In distribution | |
| 5894327P2 | In distribution | |
| 5902131P2 | In distribution | |
| 1792632 | In distribution | |
| 1792687 | In distribution | |
| 1792618 | In distribution | |
| 5896841P2 | In distribution | |
| 5903441P2 | In distribution | |
| 5902531P2 | In distribution | |
| 5897336P2 | In distribution | |
| 1792652 | In distribution | |
| 5902126P2 | In distribution | |
| 1792697 | In distribution | |
| 5903541P2 | In distribution | |
| 5905236P2 | In distribution | |
| 1792691 | In distribution | |
| 5903736P2 | In distribution | |
| 5894626P2 | In distribution | |
| 5894731P2 | In distribution | |
| 5906036 | In distribution | |
| 5902231P2 | In distribution | |
| 1792676 | In distribution | |
| 5900741P2 | In distribution | |
| 5894326P2 | In distribution | |
| 5895941P2 | In distribution | |
| 5894727P2 | In distribution | |
| 5900841P2 | In distribution | |
| 1792671 | In distribution | |
| 1792661 | In distribution | |
| 1792608 | In distribution | |
| 5895736P2 | In distribution | |
| 1792686 | In distribution | |
| 1792626 | In distribution | |
| 5897936P2 | In distribution | |
| 5897036P2 | In distribution | |
| 1792636 | In distribution | |
| 5903941P2 | In distribution | |
| 1792616 | In distribution | |
| 5894831P2 | In distribution | |
| 1792607 | In distribution | |
| 5903041P2 | In distribution | |
| 1792657 | In distribution | |
| 5905336P2 | In distribution | |
| 1792601 | In distribution | |
| 1792641 | In distribution | |
| 5897636P2 | In distribution | |
| 1792692 | In distribution | |
| 5897536P2 | In distribution | |
| 1792606 | In distribution | |
| 5902031P2 | In distribution | |
| 5894527P2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 2,299 |
| IdentiTi | Alphatec Spine, Inc. | 940 |
| Solar™ Interbody Fusion System | Degen Medical | 805 |
| Transcend Nanotec | Alphatec Spine, Inc. | 466 |
| IDENTITi Nanotec | Alphatec Spine, Inc. | 459 |
| E3D-A Interbody System | Evolution Spine, LLC | 308 |
| Battalion | Alphatec Spine, Inc. | 241 |
| Reef L | Seaspine Orthopedics Corporation | 207 |
| IdentiTi II | Alphatec Spine, Inc. | 163 |
| Modulus | Nuvasive, Inc. | 158 |
| Hedron | Globus Medical, Inc. | 156 |
| Roccia | Silony Medical Gmbh | 133 |
Showing 12 of 41. All products under Intervertebral Fusion Device With Bone Graft, Thoracic
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.