Transcend
TRANSCEND LIF PEEK SPACER, 10 x 22 x 50 mm, 10°
1manufacturer
77catalogue 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) | K191311 |
| Record published | 2020-01-10 |
| Record revised | 2022-12-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Height 4 to 14 mm; width 16 to 26 mm; angle 10 to 15 °; length 45 to 60 mm; depth 25 to 60 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 101-08184510-S | Length 45 mm | In distribution |
| 101-08225015-S | Height 8 mm | In distribution |
| 101-10225010-S | Length 50 mm | In distribution |
| 101-06164510-S | Width 16 mm | In distribution |
| 101-04224015-S | Depth 40 mm | In distribution |
| 101-10184000-S | Width 18 mm | In distribution |
| 101-10226010-S | Angle 10 ° | In distribution |
| 101-08224510-S | Angle 10 ° | In distribution |
| 101-04265510-S | Height 4 mm | In distribution |
| 101-14225500-S | Length 55 mm | In distribution |
| 101-06266000-S | Height 6 mm | In distribution |
| 101-06186000-S | Depth 60 mm | In distribution |
| 101-10225500-S | Height 10 mm | In distribution |
| 101-06224510-S | Width 22 mm | In distribution |
| 101-10185500-S | Width 18 mm | In distribution |
| 101-10186000-S | Length 60 mm | In distribution |
| 101-12224015-S | Width 22 mm | In distribution |
| 101-04185015-S | Angle 15 ° | In distribution |
| 101-08164000-S | Width 16 mm | In distribution |
| 101-06225500-S | Height 6 mm | In distribution |
| 101-08266010-S | Height 8 mm | In distribution |
| 101-09163510-S | Depth 35 mm | In distribution |
| 101-06163000-S | Depth 30 mm | In distribution |
| 101-08186015-S | Width 18 mm | In distribution |
| 101-10266010-S | Width 26 mm | In distribution |
| 101-10163010-S | Height 10 mm | In distribution |
| 101-06185515-S | Height 6 mm | In distribution |
| 101-11164500-S | Depth 45 mm | In distribution |
| 101-04225510-S | Height 4 mm | In distribution |
| 101-10185015-S | Height 10 mm | In distribution |
| 101-08163010-S | Height 8 mm | In distribution |
| 101-11163010-S | Depth 30 mm | In distribution |
| 101-12185015-S | Width 18 mm | In distribution |
| 101-12184510-S | Width 18 mm | In distribution |
| 101-08265510-S | Height 8 mm | In distribution |
| 101-09164010-S | Width 16 mm | In distribution |
| 101-08185515-S | Width 18 mm | In distribution |
| 101-08225500-S | Height 8 mm | In distribution |
| 101-10162510-S | Width 16 mm | In distribution |
| 101-11164000-S | Height 11 mm | In distribution |
| 101-08164510-S | Angle 10 ° | In distribution |
| 101-09163500-S | Height 9 mm | In distribution |
| 101-04186010-S | Height 4 mm | In distribution |
| 101-14185500-S | Length 55 mm | In distribution |
| 101-06185510-S | Width 18 mm | In distribution |
| 101-11163000-S | Width 16 mm | In distribution |
| 101-06225515-S | Angle 15 ° | In distribution |
| 101-04225015-S | Angle 15 ° | In distribution |
| 101-04225515-S | Height 4 mm | In distribution |
| 101-10224510-S | Width 22 mm | In distribution |
| 101-08225510-S | Height 8 mm | In distribution |
| 101-06224515-S | Length 45 mm | In distribution |
| 101-07163510-S | Depth 35 mm | In distribution |
| 101-08163510-S | Height 8 mm | In distribution |
| 101-14225000-S | Width 22 mm | In distribution |
| 101-12185515-S | Depth 55 mm | In distribution |
| 101-12184000-S | Depth 40 mm | In distribution |
| 101-07164510-S | Depth 45 mm | In distribution |
| 101-10224010-S | Width 22 mm | In distribution |
| 101-06185500-S | Depth 55 mm | In distribution |
| 101-08224000-S | Height 8 mm | In distribution |
| 101-06186010-S | Width 18 mm | In distribution |
| 101-10164500-S | Depth 45 mm | In distribution |
| 101-09164500-S | Depth 45 mm | In distribution |
| 101-12226000-S | Length 60 mm | In distribution |
| 101-08186010-S | Angle 10 ° | In distribution |
| 101-04185510-S | Height 4 mm | In distribution |
| 101-06264510-S | Angle 10 ° | In distribution |
| 101-06225000-S | Width 22 mm | In distribution |
| 101-06162500-S | Width 16 mm | In distribution |
| 101-12225510-S | Length 55 mm | In distribution |
| 101-06184515-S | Height 6 mm | In distribution |
| 101-08184515-S | Height 8 mm | In distribution |
| 101-04225010-S | Height 4 mm | In distribution |
| 101-12224515-S | Height 12 mm | In distribution |
| 101-12164500-S | Height 12 mm | In distribution |
| 101-07162510-S | Width 16 mm | 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.