Transcend Nanotec
TRANSCEND NANOTEC LIF-HL PEEK SPACER, 11 x 18 x 55 mm, 20°
3manufacturers in China registered for this device type
485catalogue 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) | K211805 |
| Record published | 2021-12-29 |
| Record revised | 2022-11-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Width 9 to 26 mm; height 4 to 16 mm; length 25 to 65 mm; angle 5 to 30 °; depth 22 to 35 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 101-PRO-13186010-S | Width 18 mm | In distribution |
| 101-PRO-09266010-S | Width 26 mm | In distribution |
| 101-PRO-06163010-S | Height 6 mm | In distribution |
| 101-PRO-14186515-S | Angle 15 ° | In distribution |
| 101-PRO-11185520-S | Height 11 mm | In distribution |
| 101-PRO-08264530-S | Length 45 mm | In distribution |
| 101-PRO-04185530-S | Angle 30 ° | In distribution |
| 101-PRO-13264510-S | Angle 10 ° | In distribution |
| 101-PRO-07186005-S | Length 60 mm | In distribution |
| 101-PRO-09184520-S | Angle 20 ° | In distribution |
| 144-PRO-10103010-S | Depth 30 mm | In distribution |
| 101-PRO-06224000-S | Height 6 mm | In distribution |
| 101-PRO-05224510-S | Width 22 mm | In distribution |
| 101-PRO-12265500-S | Length 55 mm | In distribution |
| 101-PRO-09185500-S | Width 18 mm | In distribution |
| 101-PRO-04265515-S | Length 55 mm | In distribution |
| 140-PRO-15093015-S | Depth 30 mm | In distribution |
| 101-PRO-07265025-S | Length 50 mm | In distribution |
| 101-PRO-09185025-S | Width 18 mm | In distribution |
| 101-PRO-05265525-S | Length 55 mm | In distribution |
| 101-PRO-09185530-S | Angle 30 ° | In distribution |
| 101-PRO-05226520-S | Length 65 mm | In distribution |
| 101-PRO-09184500-S | Length 45 mm | In distribution |
| 101-PRO-14224005-S | Height 14 mm | In distribution |
| 101-PRO-07184515-S | Length 45 mm | In distribution |
| 101-PRO-08226525-S | Width 22 mm | In distribution |
| 101-PRO-08186025-S | Height 8 mm | In distribution |
| 101-PRO-07184000-S | Length 40 mm | In distribution |
| 101-PRO-14186020-S | Width 18 mm | In distribution |
| 101-PRO-09186510-S | Angle 10 ° | In distribution |
| 101-PRO-06186530-S | Width 18 mm | In distribution |
| 101-PRO-10186505-S | Length 65 mm | In distribution |
| 101-PRO-15226000-S | Height 15 mm | In distribution |
| 101-PRO-05265510-S | Height 5 mm | In distribution |
| 101-PRO-06184505-S | Length 45 mm | In distribution |
| 101-PRO-09264005-S | Height 9 mm | In distribution |
| 101-PRO-16184500-S | Width 18 mm | In distribution |
| 101-PRO-13224525-S | Angle 25 ° | In distribution |
| 101-PRO-12185530-S | Width 18 mm | In distribution |
| 140-PRO-09093005-S | Angle 5 ° | In distribution |
| 101-PRO-07264510-S | Length 45 mm | In distribution |
| 101-PRO-05264510-S | Length 45 mm | In distribution |
| 144-PRO-13102515-S | Height 13 mm | In distribution |
| 101-PRO-04226030-S | Length 60 mm | In distribution |
| 101-PRO-11226015-S | Width 22 mm | In distribution |
| 101-PRO-07162510-S | Angle 10 ° | In distribution |
| 101-PRO-05186025-S | Height 5 mm | In distribution |
| 101-PRO-12225005-S | Width 22 mm | In distribution |
| 101-PRO-10225030-S | Angle 30 ° | In distribution |
| 101-PRO-05186015-S | Length 60 mm | In distribution |
| 101-PRO-13224025-S | Angle 25 ° | In distribution |
| 101-PRO-11265015-S | Angle 15 ° | In distribution |
| 101-PRO-14265000-S | Length 50 mm | In distribution |
| 101-PRO-12162500-S | Width 16 mm | In distribution |
| 101-PRO-05264010-S | Length 40 mm | In distribution |
| 140-PRO-14092515-S | Width 9 mm | In distribution |
| 101-PRO-04185505-S | Length 55 mm | In distribution |
| 101-PRO-06264000-S | Width 26 mm | In distribution |
| 144-PRO-10102505-S | Angle 5 ° | In distribution |
| 101-PRO-05186530-S | Length 65 mm | In distribution |
| 140-PRO-14092205-S | Height 14 mm | In distribution |
| 101-PRO-04265025-S | Width 26 mm | In distribution |
| 101-PRO-14264520-S | Height 14 mm | In distribution |
| 101-PRO-14224015-S | Length 40 mm | In distribution |
| 144-PRO-12103505-S | Width 10 mm | In distribution |
| 101-PRO-14225520-S | Width 22 mm | In distribution |
| 101-PRO-12185510-S | Length 55 mm | In distribution |
| 101-PRO-08224500-S | Height 8 mm | In distribution |
| 101-PRO-12266015-S | Length 60 mm | In distribution |
| 101-PRO-14185015-S | Length 50 mm | In distribution |
| 101-PRO-09265505-S | Width 26 mm | In distribution |
| 101-PRO-14184515-S | Length 45 mm | In distribution |
| 101-PRO-11266510-S | Length 65 mm | In distribution |
| 101-PRO-13184000-S | Length 40 mm | In distribution |
| 101-PRO-12225025-S | Height 12 mm | In distribution |
| 101-PRO-16184000-S | Length 40 mm | In distribution |
| 101-PRO-11264015-S | Length 40 mm | In distribution |
| 101-PRO-12185025-S | Length 50 mm | In distribution |
| 101-PRO-10266025-S | Length 60 mm | In distribution |
| 101-PRO-06264015-S | Length 40 mm | In distribution |
| 101-PRO-08225510-S | Height 8 mm | In distribution |
| 101-PRO-11184025-S | Height 11 mm | In distribution |
| 101-PRO-04185525-S | Height 4 mm | In distribution |
| 101-PRO-06264020-S | Angle 20 ° | In distribution |
| 101-PRO-11186525-S | Angle 25 ° | In distribution |
| 101-PRO-06185500-S | Height 6 mm | In distribution |
| 101-PRO-07226530-S | Angle 30 ° | In distribution |
| 101-PRO-11226020-S | Length 60 mm | In distribution |
| 101-PRO-11264515-S | Length 45 mm | In distribution |
| 101-PRO-14164510-S | Height 14 mm | In distribution |
| 101-PRO-16224500-S | Width 22 mm | In distribution |
| 101-PRO-09265025-S | Width 26 mm | In distribution |
| 101-PRO-13184505-S | Width 18 mm | In distribution |
| 101-PRO-07185515-S | Height 7 mm | In distribution |
| 101-PRO-09185015-S | Length 50 mm | In distribution |
| 101-PRO-11185505-S | Angle 5 ° | In distribution |
| 101-PRO-05184025-S | Height 5 mm | In distribution |
| 101-PRO-08184520-S | Angle 20 ° | In distribution |
| 101-PRO-09224005-S | Width 22 mm | In distribution |
| 101-PRO-10226510-S | Height 10 mm | In distribution |
| 101-PRO-10164000-S | Width 16 mm | In distribution |
| 144-PRO-07103005-S | Angle 5 ° | In distribution |
| 101-PRO-09224525-S | Height 9 mm | In distribution |
| 101-PRO-10224005-S | Angle 5 ° | In distribution |
| 101-PRO-08225000-S | Length 50 mm | In distribution |
| 101-PRO-06226030-S | Length 60 mm | In distribution |
| 101-PRO-14226500-S | Height 14 mm | In distribution |
| 101-PRO-13264005-S | Width 26 mm | In distribution |
| 101-PRO-10226025-S | Length 60 mm | In distribution |
| 101-PRO-12264020-S | Width 26 mm | In distribution |
| 101-PRO-11186510-S | Width 18 mm | In distribution |
| 101-PRO-11163500-S | Width 16 mm | In distribution |
| 101-PRO-04186520-S | Angle 20 ° | In distribution |
| 101-PRO-14265515-S | Width 26 mm | In distribution |
| 140-PRO-10092515-S | Angle 15 ° | In distribution |
| 101-PRO-07163510-S | Width 16 mm | In distribution |
| 101-PRO-14185010-S | Length 50 mm | In distribution |
| 101-PRO-10224530-S | Angle 30 ° | In distribution |
| 101-PRO-06186005-S | Length 60 mm | In distribution |
| 101-PRO-08184505-S | Length 45 mm | In distribution |
| 101-PRO-09186025-S | Length 60 mm | In distribution |
| 101-PRO-05184505-S | Length 45 mm | In distribution |
| 101-PRO-14266500-S | Length 65 mm | In distribution |
| 140-PRO-07092500-S | Height 7 mm | In distribution |
| 101-PRO-16224000-S | Width 22 mm | In distribution |
| 101-PRO-13164510-S | Angle 10 ° | In distribution |
| 101-PRO-12184030-S | Height 12 mm | In distribution |
| 101-PRO-12266010-S | Width 26 mm | In distribution |
| 101-PRO-09224500-S | Height 9 mm | In distribution |
| 101-PRO-11225510-S | Angle 10 ° | In distribution |
| 101-PRO-14226005-S | Length 60 mm | In distribution |
| 101-PRO-09265520-S | Length 55 mm | In distribution |
| 101-PRO-12185010-S | Width 18 mm | In distribution |
| 101-PRO-11225025-S | Width 22 mm | In distribution |
| 101-PRO-05225005-S | Angle 5 ° | In distribution |
| 101-PRO-07266525-S | Length 65 mm | In distribution |
| 101-PRO-16162500-S | Length 25 mm | In distribution |
| 101-PRO-10185010-S | Length 50 mm | In distribution |
| 101-PRO-12184005-S | Length 40 mm | In distribution |
| 144-PRO-14103010-S | Width 10 mm | In distribution |
| 101-PRO-12185525-S | Height 12 mm | In distribution |
| 101-PRO-11186520-S | Width 18 mm | In distribution |
| 101-PRO-11266025-S | Length 60 mm | In distribution |
| 101-PRO-07184025-S | Width 18 mm | In distribution |
| 101-PRO-08186510-S | Length 65 mm | In distribution |
| 101-PRO-09184010-S | Length 40 mm | In distribution |
| 101-PRO-09163500-S | Width 16 mm | In distribution |
| 101-PRO-05265015-S | Height 5 mm | In distribution |
| 101-PRO-06226500-S | Length 65 mm | In distribution |
| 101-PRO-13225005-S | Length 50 mm | In distribution |
| 101-PRO-05185020-S | Angle 20 ° | In distribution |
| 101-PRO-09266015-S | Angle 15 ° | In distribution |
| 101-PRO-04224010-S | Length 40 mm | In distribution |
| 101-PRO-08186500-S | Length 65 mm | In distribution |
| 101-PRO-14226015-S | Height 14 mm | In distribution |
| 101-PRO-07184010-S | Length 40 mm | In distribution |
| 144-PRO-07103515-S | Height 7 mm | In distribution |
| 101-PRO-09224000-S | Length 40 mm | In distribution |
| 101-PRO-12264510-S | Height 12 mm | In distribution |
| 101-PRO-16264000-S | Height 16 mm | In distribution |
| 101-PRO-13264500-S | Width 26 mm | In distribution |
| 101-PRO-09266030-S | Angle 30 ° | In distribution |
| 101-PRO-09224530-S | Angle 30 ° | In distribution |
| 101-PRO-09184510-S | Width 18 mm | In distribution |
| 101-PRO-04184525-S | Width 18 mm | In distribution |
| 140-PRO-07092205-S | Depth 22 mm | In distribution |
| 101-PRO-09224510-S | Angle 10 ° | In distribution |
| 101-PRO-04225025-S | Length 50 mm | In distribution |
| 101-PRO-10184025-S | Angle 25 ° | In distribution |
| 101-PRO-14186525-S | Height 14 mm | In distribution |
| 101-PRO-08224515-S | Length 45 mm | In distribution |
| 101-PRO-10186005-S | Length 60 mm | In distribution |
| 140-PRO-09092510-S | Angle 10 ° | In distribution |
| 101-PRO-12184020-S | Width 18 mm | In distribution |
| 101-PRO-13186030-S | Length 60 mm | In distribution |
| 101-PRO-14224000-S | Width 22 mm | In distribution |
| 101-PRO-04186030-S | Width 18 mm | In distribution |
| 101-PRO-10225020-S | Length 50 mm | In distribution |
| 101-PRO-07265000-S | Width 26 mm | In distribution |
| 101-PRO-12185005-S | Angle 5 ° | In distribution |
| 101-PRO-07226020-S | Length 60 mm | In distribution |
| 101-PRO-06184000-S | Height 6 mm | In distribution |
| 101-PRO-10226030-S | Angle 30 ° | In distribution |
| 101-PRO-13224015-S | Angle 15 ° | In distribution |
| 101-PRO-05265520-S | Height 5 mm | In distribution |
| 101-PRO-06224020-S | Height 6 mm | In distribution |
| 101-PRO-14264005-S | Width 26 mm | In distribution |
| 101-PRO-05185530-S | Angle 30 ° | In distribution |
| 101-PRO-06225010-S | Height 6 mm | In distribution |
| 101-PRO-10264510-S | Height 10 mm | In distribution |
| 101-PRO-09186030-S | Length 60 mm | In distribution |
| 101-PRO-05265505-S | Length 55 mm | In distribution |
| 101-PRO-10185500-S | Width 18 mm | In distribution |
| 101-PRO-11265505-S | Height 11 mm | In distribution |
| 101-PRO-08265500-S | Height 8 mm | In distribution |
| 101-PRO-10224500-S | Length 45 mm | In distribution |
| 101-PRO-06225025-S | Length 50 mm | In distribution |
| 101-PRO-12226025-S | Length 60 mm | In distribution |
| 101-PRO-11224510-S | Angle 10 ° | In distribution |
| 101-PRO-09185010-S | Width 18 mm | In distribution |
| 101-PRO-04184030-S | Length 40 mm | In distribution |
| 101-PRO-09163010-S | Height 9 mm | In distribution |
| 101-PRO-08225500-S | Length 55 mm | In distribution |
| 101-PRO-06186000-S | Width 18 mm | In distribution |
| 101-PRO-13184530-S | Length 45 mm | In distribution |
| 101-PRO-10184500-S | Width 18 mm | In distribution |
| 101-PRO-05266530-S | Width 26 mm | In distribution |
| 101-PRO-15162500-S | Width 16 mm | In distribution |
| 101-PRO-04184015-S | Height 4 mm | In distribution |
| 101-PRO-15226500-S | Length 65 mm | In distribution |
| 144-PRO-07103510-S | Depth 35 mm | In distribution |
| 101-PRO-13226020-S | Length 60 mm | In distribution |
| 101-PRO-13264020-S | Width 26 mm | In distribution |
| 101-PRO-10265000-S | Width 26 mm | In distribution |
| 101-PRO-08266525-S | Width 26 mm | In distribution |
| 101-PRO-11265525-S | Angle 25 ° | In distribution |
| 101-PRO-08184525-S | Height 8 mm | In distribution |
| 101-PRO-05264525-S | Width 26 mm | In distribution |
| 101-PRO-14184520-S | Angle 20 ° | In distribution |
| 101-PRO-13264010-S | Angle 10 ° | In distribution |
| 101-PRO-07184505-S | Length 45 mm | In distribution |
| 101-PRO-04266005-S | Angle 5 ° | In distribution |
| 101-PRO-14186510-S | Length 65 mm | In distribution |
| 144-PRO-08102515-S | Height 8 mm | In distribution |
| 101-PRO-11265020-S | Angle 20 ° | In distribution |
| 101-PRO-11266500-S | Height 11 mm | In distribution |
| 101-PRO-11226510-S | Width 22 mm | In distribution |
| 101-PRO-09186505-S | Width 18 mm | In distribution |
| 101-PRO-13184030-S | Height 13 mm | In distribution |
| 101-PRO-06224515-S | Width 22 mm | In distribution |
| 101-PRO-07186025-S | Length 60 mm | In distribution |
| 101-PRO-09164010-S | Length 40 mm | In distribution |
| 101-PRO-04186515-S | Length 65 mm | In distribution |
| 101-PRO-09225005-S | Length 50 mm | In distribution |
| 140-PRO-08092510-S | Angle 10 ° | In distribution |
| 101-PRO-06264505-S | Height 6 mm | In distribution |
| 101-PRO-14226515-S | Length 65 mm | In distribution |
| 101-PRO-12185500-S | Height 12 mm | In distribution |
| 101-PRO-11226530-S | Length 65 mm | In distribution |
| 101-PRO-04184520-S | Width 18 mm | In distribution |
| 101-PRO-07264525-S | Width 26 mm | In distribution |
| 101-PRO-07184030-S | Length 40 mm | In distribution |
| 101-PRO-16226500-S | Width 22 mm | In distribution |
| 101-PRO-05225510-S | Height 5 mm | In distribution |
| 101-PRO-11184030-S | Angle 30 ° | In distribution |
| 140-PRO-11092205-S | Width 9 mm | In distribution |
| 101-PRO-12225525-S | Width 22 mm | In distribution |
| 101-PRO-09264505-S | Width 26 mm | In distribution |
| 101-PRO-11224005-S | Height 11 mm | In distribution |
| 101-PRO-07265510-S | Length 55 mm | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
| IDENTITi Nanotec | Alphatec Spine, Inc. | 453 |
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.