Calibrate
LTX NANOTEC HL SPACER, 6 x 22 x 50 mm, 30°
1manufacturer
50catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Alphatec Spine, 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) | K222455 |
| Record published | 2023-01-05 |
| Record revised | 2025-04-30 (version 3) |
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 |
| Sizes | Length 30 to 60 mm; height 6 to 8 mm; angle 15 to 30 °; width 18 to 22 mm; outer diameter 5 to 5.5 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 257-06226015 | Length 60 mm | In distribution |
| 261-PRO-06225030-S | Angle 30 ° | In distribution |
| 261-PRO-06224530-S | Length 45 mm | In distribution |
| 262-110 | In distribution | |
| 261-06184515 | In distribution | |
| 261-PRO-06225530-S | Length 55 mm | In distribution |
| 262-06226020 | In distribution | |
| 261-PRO-08186015-S | Height 8 mm | In distribution |
| 259-5555 | Outer Diameter 5.5 mm | In distribution |
| 261-06225015 | In distribution | |
| 257-06186015 | Height 6 mm | In distribution |
| 257-06184520 | Length 45 mm | In distribution |
| 261-06186015-D | In distribution | |
| 261-06185520 | In distribution | |
| 261-06224515-D | In distribution | |
| 257-06225515 | Width 22 mm | In distribution |
| 261-06184520 | In distribution | |
| 261-06186015 | In distribution | |
| 261-PRO-06225520-S | Length 55 mm | In distribution |
| 261-06225520-D | In distribution | |
| 262-06186020 | In distribution | |
| 261-PRO-06185020-S | Height 6 mm | In distribution |
| 257-06225520 | Width 22 mm | In distribution |
| 261-06185020 | In distribution | |
| 257-06185020 | Length 50 mm | In distribution |
| 257-06226030 | Height 6 mm | In distribution |
| 261-PRO-08185515-S | Angle 15 ° | In distribution |
| 261-06225020 | In distribution | |
| 261-06184520-D | In distribution | |
| 261-06224520-D | In distribution | |
| 261-PRO-08184515-S | Length 45 mm | In distribution |
| 259-5540 | Length 40 mm | In distribution |
| 261-06225515 | In distribution | |
| 261-06225020-D | In distribution | |
| 257-06185015 | Width 18 mm | In distribution |
| 261-06226020 | In distribution | |
| 261-06226015-D | In distribution | |
| 258-300 | In distribution | |
| 259-5035 | Length 35 mm | In distribution |
| 259-5040 | Outer Diameter 5 mm | In distribution |
| 261-PRO-06184520-S | Width 18 mm | In distribution |
| 261-06226015 | In distribution | |
| 261-06185515-D | In distribution | |
| 259-5055 | Length 55 mm | In distribution |
| 261-06185520-D | In distribution | |
| 259-5530 | Outer Diameter 5.5 mm | In distribution |
| 257-06226020 | Height 6 mm | In distribution |
| 261-06186020 | In distribution | |
| 262-200 | In distribution | |
| 261-06184515-D | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180480 | 2018-05-31 |
| K160958 | 2016-09-08 |
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.