Transcend
TRANSCEND LIF PEEK SPACER, 12 x 22 x 40 mm, 10°
3manufacturers in China registered for this device type
101catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| 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 38 mm; angle 10 to 20 °; length 24 to 60 mm; depth 25 to 60 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 101-06184510-S | Height 6 mm | In distribution |
| 101-12224500-S | Height 12 mm | In distribution |
| 101-12224010-S | Height 12 mm | In distribution |
| 101-12184010-S | Height 12 mm | In distribution |
| 101-12224510-S | Height 12 mm | In distribution |
| 101-04226010-S | Height 4 mm | In distribution |
| 101-10163500-S | Height 10 mm | In distribution |
| 101-10185010-S | Angle 10 ° | In distribution |
| 101-12185500-S | Width 18 mm | In distribution |
| 101-08264510-S | Height 8 mm | In distribution |
| 101-06266010-S | Length 60 mm | In distribution |
| 101-10226000-S | Height 10 mm | In distribution |
| 101-12225015-S | Width 22 mm | In distribution |
| 101-06264500-S | Width 26 mm | In distribution |
| 101-09163010-S | Depth 30 mm | In distribution |
| 101-06224000-S | Width 22 mm | In distribution |
| 101-10185000-S | Height 10 mm | In distribution |
| 101-09162500-S | Height 9 mm | In distribution |
| 101-04184515-S | Width 18 mm | In distribution |
| 101-04224515-S | Angle 15 ° | In distribution |
| 101-12226010-S | Angle 10 ° | In distribution |
| 101-06226000-S | Height 6 mm | In distribution |
| 101-12185000-S | Height 12 mm | In distribution |
| 101-08224015-S | Width 22 mm | In distribution |
| 833-08382820-S | Height 8 mm | In distribution |
| 833-06342415-S | Width 34 mm | In distribution |
| 101-08185510-S | Width 18 mm | In distribution |
| 833-10342410-S | Height 10 mm | In distribution |
| 101-12163510-S | Depth 35 mm | In distribution |
| 101-04264010-S | Height 4 mm | In distribution |
| 101-08265010-S | Length 50 mm | In distribution |
| 101-04184510-S | Width 18 mm | In distribution |
| 101-12163010-S | Angle 10 ° | In distribution |
| 101-06184500-S | Width 18 mm | In distribution |
| 101-08185015-S | Length 50 mm | In distribution |
| 101-08225000-S | Height 8 mm | In distribution |
| 101-14184500-S | Width 18 mm | In distribution |
| 101-10264510-S | Width 26 mm | In distribution |
| 101-12163500-S | Depth 35 mm | In distribution |
| 101-06185010-S | Length 50 mm | In distribution |
| 101-10164000-S | Width 16 mm | In distribution |
| 101-12225500-S | Width 22 mm | In distribution |
| 101-06164000-S | Height 6 mm | In distribution |
| 833-07382810-S | Width 38 mm | In distribution |
| 101-10164510-S | Width 16 mm | In distribution |
| 101-10185510-S | Angle 10 ° | In distribution |
| 101-08226010-S | Angle 10 ° | In distribution |
| 101-12185010-S | Height 12 mm | In distribution |
| 101-10226015-S | Height 10 mm | In distribution |
| 101-10224015-S | Angle 15 ° | In distribution |
| 101-12225515-S | Height 12 mm | In distribution |
| 833-06342412-S | Angle 12 ° | In distribution |
| 101-07163000-S | Width 16 mm | In distribution |
| 101-14185000-S | Width 18 mm | In distribution |
| 101-12163000-S | Depth 30 mm | In distribution |
| 101-10185515-S | Width 18 mm | In distribution |
| 101-07164010-S | Angle 10 ° | In distribution |
| 833-09382815-S | Angle 15 ° | In distribution |
| 101-04185010-S | Angle 10 ° | In distribution |
| 101-10163000-S | Height 10 mm | In distribution |
| 833-11382810-S | Length 28 mm | In distribution |
| 833-08342415-S | Width 34 mm | In distribution |
| 833-06342420-S | Width 34 mm | In distribution |
| 101-06185000-S | Depth 50 mm | In distribution |
| 101-11162510-S | Width 16 mm | In distribution |
| 101-10186010-S | Length 60 mm | In distribution |
| 101-08162510-S | Depth 25 mm | In distribution |
| 101-11163500-S | Depth 35 mm | In distribution |
| 101-04184010-S | Height 4 mm | In distribution |
| 101-06186015-S | Height 6 mm | In distribution |
| 101-14184000-S | Height 14 mm | In distribution |
| 101-10224500-S | Width 22 mm | In distribution |
| 101-14224000-S | Depth 40 mm | In distribution |
| 833-06382820-S | Height 6 mm | In distribution |
| 101-07164000-S | Height 7 mm | In distribution |
| 101-08184010-S | Width 18 mm | In distribution |
| 833-11382815-S | Width 38 mm | In distribution |
| 101-12186000-S | Length 60 mm | In distribution |
| 833-04382820-S | Length 28 mm | In distribution |
| 833-07382815-S | Angle 15 ° | In distribution |
| 101-12224000-S | Width 22 mm | In distribution |
| 101-06264010-S | Width 26 mm | In distribution |
| 101-09164000-S | Width 16 mm | In distribution |
| 101-06184015-S | Depth 40 mm | In distribution |
| 101-10184015-S | Depth 40 mm | In distribution |
| 101-12162500-S | Width 16 mm | In distribution |
| 101-07164500-S | Height 7 mm | In distribution |
| 101-08185010-S | Height 8 mm | In distribution |
| 101-09163000-S | Depth 30 mm | In distribution |
| 101-06226010-S | Height 6 mm | In distribution |
| 101-10162500-S | Width 16 mm | In distribution |
| 101-08225515-S | Length 55 mm | In distribution |
| 101-07163500-S | Width 16 mm | In distribution |
| 101-07163010-S | Depth 30 mm | In distribution |
| 833-05382815-S | Angle 15 ° | In distribution |
| 101-10184500-S | Height 10 mm | In distribution |
| 101-12266010-S | Height 12 mm | In distribution |
| 101-06184000-S | Height 6 mm | In distribution |
| 101-12225010-S | Angle 10 ° | In distribution |
| 101-08264010-S | Height 8 mm | In distribution |
| 101-06184010-S | Width 18 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251575 | 2025-09-03 |
| K232097 | 2023-09-25 |
| K203742 | 2021-04-09 |
| K123993 | 2013-03-05 |
| K102402 | 2011-03-30 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-01-26 | Class II | Device Design | Due to reports of intraoperative graft bolt implantation breakages. | 12,777 devices |
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.