IDENTITi Nanotec
IDENTITi NANOTEC LIF-HL POROUS Ti SPACER, 13 x 22 x 40 mm, 25°
3manufacturers in China registered for this device type
453catalogue 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 | 2025-07-14 (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 16 to 26 mm; height 4 to 16 mm; length 25 to 65 mm; angle 5 to 30 ° |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100-PRO-09186525-S | Width 18 mm | In distribution |
| 100-PRO-13226005-S | Height 13 mm | In distribution |
| 100-PRO-12164010-S | Length 40 mm | In distribution |
| 100-PRO-07184005-S | Height 7 mm | In distribution |
| 100-PRO-10265005-S | Angle 5 ° | In distribution |
| 100-PRO-09266030-S | Angle 30 ° | In distribution |
| 100-PRO-06186520-S | Length 65 mm | In distribution |
| 100-PRO-04266025-S | Length 60 mm | In distribution |
| 100-PRO-11185515-S | Width 18 mm | In distribution |
| 100-PRO-09185020-S | Length 50 mm | In distribution |
| 100-PRO-11264010-S | Width 26 mm | In distribution |
| 100-PRO-08185005-S | Width 18 mm | In distribution |
| 100-PRO-05266520-S | Width 26 mm | In distribution |
| 100-PRO-07225505-S | Length 55 mm | In distribution |
| 100-PRO-13224025-S | Length 40 mm | In distribution |
| 100-PRO-08264515-S | Length 45 mm | In distribution |
| 100-PRO-04186015-S | Height 4 mm | In distribution |
| 100-PRO-11186005-S | Height 11 mm | In distribution |
| 100-PRO-11225010-S | Height 11 mm | In distribution |
| 100-PRO-08265025-S | Width 26 mm | In distribution |
| 100-PRO-11264500-S | Width 26 mm | In distribution |
| 100-PRO-04264005-S | Height 4 mm | In distribution |
| 100-PRO-10185505-S | Height 10 mm | In distribution |
| 100-PRO-14184525-S | Angle 25 ° | In distribution |
| 100-PRO-10224000-S | Width 22 mm | In distribution |
| 100-PRO-04186520-S | Length 65 mm | In distribution |
| 100-PRO-10186000-S | Height 10 mm | In distribution |
| 100-PRO-12184530-S | Angle 30 ° | In distribution |
| 100-PRO-08225015-S | Angle 15 ° | In distribution |
| 100-PRO-07226025-S | Angle 25 ° | In distribution |
| 100-PRO-05184515-S | Length 45 mm | In distribution |
| 100-PRO-04264030-S | Width 26 mm | In distribution |
| 100-PRO-13264005-S | Length 40 mm | In distribution |
| 100-PRO-15224000-S | Height 15 mm | In distribution |
| 100-PRO-16264500-S | Length 45 mm | In distribution |
| 100-PRO-13186005-S | Angle 5 ° | In distribution |
| 100-PRO-07185025-S | Width 18 mm | In distribution |
| 100-PRO-09184515-S | Width 18 mm | In distribution |
| 100-PRO-13225520-S | Width 22 mm | In distribution |
| 100-PRO-08266530-S | Height 8 mm | In distribution |
| 100-PRO-09185000-S | Width 18 mm | In distribution |
| 100-PRO-13226025-S | Length 60 mm | In distribution |
| 100-PRO-06185520-S | Length 55 mm | In distribution |
| 100-PRO-11264510-S | Width 26 mm | In distribution |
| 100-PRO-13266010-S | Height 13 mm | In distribution |
| 100-PRO-08266515-S | Height 8 mm | In distribution |
| 100-PRO-08186020-S | Length 60 mm | In distribution |
| 100-PRO-11225505-S | Width 22 mm | In distribution |
| 100-PRO-05224010-S | Width 22 mm | In distribution |
| 100-PRO-04266530-S | Angle 30 ° | In distribution |
| 100-PRO-10184000-S | Height 10 mm | In distribution |
| 100-PRO-04266520-S | Length 65 mm | In distribution |
| 100-PRO-10163500-S | Height 10 mm | In distribution |
| 100-PRO-09266015-S | Length 60 mm | In distribution |
| 100-PRO-13184005-S | Length 40 mm | In distribution |
| 100-PRO-14266015-S | Width 26 mm | In distribution |
| 100-PRO-09265500-S | Length 55 mm | In distribution |
| 100-PRO-12226010-S | Angle 10 ° | In distribution |
| 100-PRO-11225530-S | Angle 30 ° | In distribution |
| 100-PRO-13185030-S | Height 13 mm | In distribution |
| 100-PRO-13224525-S | Length 45 mm | In distribution |
| 100-PRO-11186515-S | Height 11 mm | In distribution |
| 100-PRO-12225005-S | Height 12 mm | In distribution |
| 100-PRO-10265015-S | Length 50 mm | In distribution |
| 100-PRO-13265515-S | Length 55 mm | In distribution |
| 100-PRO-12264500-S | Length 45 mm | In distribution |
| 100-PRO-05186020-S | Angle 20 ° | In distribution |
| 100-PRO-08226500-S | Height 8 mm | In distribution |
| 100-PRO-05226510-S | Angle 10 ° | In distribution |
| 100-PRO-06224030-S | Angle 30 ° | In distribution |
| 100-PRO-13224500-S | Height 13 mm | In distribution |
| 100-PRO-09265005-S | Height 9 mm | In distribution |
| 100-PRO-10265510-S | Width 26 mm | In distribution |
| 100-PRO-13224505-S | Width 22 mm | In distribution |
| 100-PRO-12264505-S | Width 26 mm | In distribution |
| 100-PRO-16264000-S | Width 26 mm | In distribution |
| 100-PRO-08225030-S | Angle 30 ° | In distribution |
| 100-PRO-07224010-S | Width 22 mm | In distribution |
| 100-PRO-08266510-S | Width 26 mm | In distribution |
| 100-PRO-06186000-S | Width 18 mm | In distribution |
| 100-PRO-12184510-S | Height 12 mm | In distribution |
| 100-PRO-09186530-S | Angle 30 ° | In distribution |
| 100-PRO-13264010-S | Length 40 mm | In distribution |
| 100-PRO-07225530-S | Angle 30 ° | In distribution |
| 100-PRO-14225505-S | Height 14 mm | In distribution |
| 100-PRO-04185020-S | Angle 20 ° | In distribution |
| 100-PRO-10225010-S | Length 50 mm | In distribution |
| 100-PRO-09186515-S | Width 18 mm | In distribution |
| 100-PRO-14265520-S | Length 55 mm | In distribution |
| 100-PRO-10185525-S | Height 10 mm | In distribution |
| 100-PRO-06266000-S | Height 6 mm | In distribution |
| 100-PRO-10184010-S | Angle 10 ° | In distribution |
| 100-PRO-12185510-S | Width 18 mm | In distribution |
| 100-PRO-12264010-S | Length 40 mm | In distribution |
| 100-PRO-10226505-S | Width 22 mm | In distribution |
| 100-PRO-10224030-S | Width 22 mm | In distribution |
| 100-PRO-10265000-S | Length 50 mm | In distribution |
| 100-PRO-10185530-S | Length 55 mm | In distribution |
| 100-PRO-12184015-S | Angle 15 ° | In distribution |
| 100-PRO-09185015-S | Angle 15 ° | In distribution |
| 100-PRO-14184030-S | Angle 30 ° | In distribution |
| 100-PRO-09225510-S | Height 9 mm | In distribution |
| 100-PRO-06264025-S | Length 40 mm | In distribution |
| 100-PRO-09186510-S | Width 18 mm | In distribution |
| 100-PRO-09225520-S | Height 9 mm | In distribution |
| 100-PRO-05225020-S | Width 22 mm | In distribution |
| 100-PRO-15264000-S | Length 40 mm | In distribution |
| 100-PRO-13185015-S | Height 13 mm | In distribution |
| 100-PRO-04226015-S | Height 4 mm | In distribution |
| 100-PRO-04186525-S | Length 65 mm | In distribution |
| 100-PRO-07164510-S | Height 7 mm | In distribution |
| 100-PRO-09225500-S | Height 9 mm | In distribution |
| 100-PRO-11185005-S | Height 11 mm | In distribution |
| 100-PRO-13224005-S | Height 13 mm | In distribution |
| 100-PRO-14226020-S | Width 22 mm | In distribution |
| 100-PRO-11164500-S | Height 11 mm | In distribution |
| 100-PRO-10186530-S | Height 10 mm | In distribution |
| 100-PRO-12264510-S | Width 26 mm | In distribution |
| 100-PRO-12226005-S | Length 60 mm | In distribution |
| 100-PRO-06226000-S | Height 6 mm | In distribution |
| 100-PRO-11264005-S | Height 11 mm | In distribution |
| 100-PRO-09164000-S | Width 16 mm | In distribution |
| 100-PRO-10185025-S | Width 18 mm | In distribution |
| 100-PRO-08225520-S | Angle 20 ° | In distribution |
| 100-PRO-14184520-S | Height 14 mm | In distribution |
| 100-PRO-05266510-S | Height 5 mm | In distribution |
| 100-PRO-07266530-S | Height 7 mm | In distribution |
| 100-PRO-04264520-S | Width 26 mm | In distribution |
| 100-PRO-15185500-S | Width 18 mm | In distribution |
| 100-PRO-13224520-S | Length 45 mm | In distribution |
| 100-PRO-06266020-S | Width 26 mm | In distribution |
| 100-PRO-07265030-S | Angle 30 ° | In distribution |
| 100-PRO-14184510-S | Height 14 mm | In distribution |
| 100-PRO-13184010-S | Angle 10 ° | In distribution |
| 100-PRO-07163010-S | Height 7 mm | In distribution |
| 100-PRO-09265530-S | Length 55 mm | In distribution |
| 100-PRO-10265505-S | Width 26 mm | In distribution |
| 100-PRO-11266500-S | Length 65 mm | In distribution |
| 100-PRO-07224025-S | Height 7 mm | In distribution |
| 100-PRO-10224025-S | Length 40 mm | In distribution |
| 100-PRO-06265525-S | Height 6 mm | In distribution |
| 100-PRO-08164000-S | Height 8 mm | In distribution |
| 100-PRO-14225020-S | Height 14 mm | In distribution |
| 100-PRO-09224510-S | Height 9 mm | In distribution |
| 100-PRO-06186015-S | Width 18 mm | In distribution |
| 100-PRO-14185530-S | Length 55 mm | In distribution |
| 100-PRO-06224520-S | Length 45 mm | In distribution |
| 100-PRO-13186015-S | Angle 15 ° | In distribution |
| 100-PRO-07266005-S | Length 60 mm | In distribution |
| 100-PRO-05184020-S | Angle 20 ° | In distribution |
| 100-PRO-11225025-S | Length 50 mm | In distribution |
| 100-PRO-14186020-S | Height 14 mm | In distribution |
| 100-PRO-11224510-S | Angle 10 ° | In distribution |
| 100-PRO-09226525-S | Length 65 mm | In distribution |
| 100-PRO-10225520-S | Length 55 mm | In distribution |
| 100-PRO-07184000-S | Width 18 mm | In distribution |
| 100-PRO-09264520-S | Width 26 mm | In distribution |
| 100-PRO-11266525-S | Length 65 mm | In distribution |
| 100-PRO-10225020-S | Width 22 mm | In distribution |
| 100-PRO-14224500-S | Height 14 mm | In distribution |
| 100-PRO-14224010-S | Length 40 mm | In distribution |
| 100-PRO-13224515-S | Width 22 mm | In distribution |
| 100-PRO-08184520-S | Angle 20 ° | In distribution |
| 100-PRO-10225505-S | Height 10 mm | In distribution |
| 100-PRO-07185500-S | Length 55 mm | In distribution |
| 100-PRO-13186515-S | Width 18 mm | In distribution |
| 100-PRO-10226015-S | Angle 15 ° | In distribution |
| 100-PRO-09186505-S | Length 65 mm | In distribution |
| 100-PRO-12162500-S | Width 16 mm | In distribution |
| 100-PRO-06186510-S | Angle 10 ° | In distribution |
| 100-PRO-06224005-S | Width 22 mm | In distribution |
| 100-PRO-10264520-S | Length 45 mm | In distribution |
| 100-PRO-06163010-S | Length 30 mm | In distribution |
| 100-PRO-15186500-S | Height 15 mm | In distribution |
| 100-PRO-11264015-S | Width 26 mm | In distribution |
| 100-PRO-09226520-S | Length 65 mm | In distribution |
| 100-PRO-09185515-S | Height 9 mm | In distribution |
| 100-PRO-10226520-S | Height 10 mm | In distribution |
| 100-PRO-13185005-S | Height 13 mm | In distribution |
| 100-PRO-08184005-S | Angle 5 ° | In distribution |
| 100-PRO-08224010-S | Width 22 mm | In distribution |
| 100-PRO-08225500-S | Width 22 mm | In distribution |
| 100-PRO-12185530-S | Length 55 mm | In distribution |
| 100-PRO-04265515-S | Length 55 mm | In distribution |
| 100-PRO-09266025-S | Height 9 mm | In distribution |
| 100-PRO-13226505-S | Width 22 mm | In distribution |
| 100-PRO-08163500-S | Width 16 mm | In distribution |
| 100-PRO-04266030-S | Length 60 mm | In distribution |
| 100-PRO-07226015-S | Width 22 mm | In distribution |
| 100-PRO-14224000-S | Width 22 mm | In distribution |
| 100-PRO-10226020-S | Angle 20 ° | In distribution |
| 100-PRO-05226030-S | Width 22 mm | In distribution |
| 100-PRO-10224010-S | Height 10 mm | In distribution |
| 100-PRO-04226520-S | Angle 20 ° | In distribution |
| 100-PRO-12164000-S | Width 16 mm | In distribution |
| 100-PRO-14264510-S | Angle 10 ° | In distribution |
| 100-PRO-13266510-S | Angle 10 ° | In distribution |
| 100-PRO-13186510-S | Width 18 mm | In distribution |
| 100-PRO-08265030-S | Width 26 mm | In distribution |
| 100-PRO-11264000-S | Length 40 mm | In distribution |
| 100-PRO-14225000-S | Height 14 mm | In distribution |
| 100-PRO-05264505-S | Angle 5 ° | In distribution |
| 100-PRO-07163000-S | Height 7 mm | In distribution |
| 100-PRO-07225500-S | Height 7 mm | In distribution |
| 100-PRO-14265005-S | Height 14 mm | In distribution |
| 100-PRO-09225020-S | Angle 20 ° | In distribution |
| 100-PRO-10185500-S | Length 55 mm | In distribution |
| 100-PRO-07226530-S | Height 7 mm | In distribution |
| 100-PRO-04226020-S | Height 4 mm | In distribution |
| 100-PRO-08184505-S | Length 45 mm | In distribution |
| 100-PRO-09184510-S | Height 9 mm | In distribution |
| 100-PRO-05265030-S | Angle 30 ° | In distribution |
| 100-PRO-05266015-S | Width 26 mm | In distribution |
| 100-PRO-09184025-S | Width 18 mm | In distribution |
| 100-PRO-06225510-S | Height 6 mm | In distribution |
| 100-PRO-11264025-S | Angle 25 ° | In distribution |
| 100-PRO-16185500-S | Width 18 mm | In distribution |
| 100-PRO-11225500-S | Height 11 mm | In distribution |
| 100-PRO-11266020-S | Height 11 mm | In distribution |
| 100-PRO-07264505-S | Height 7 mm | In distribution |
| 100-PRO-13265005-S | Height 13 mm | In distribution |
| 100-PRO-07184505-S | Length 45 mm | In distribution |
| 100-PRO-11185530-S | Width 18 mm | In distribution |
| 100-PRO-10226515-S | Angle 15 ° | In distribution |
| 100-PRO-08224005-S | Height 8 mm | In distribution |
| 100-PRO-08185010-S | Width 18 mm | In distribution |
| 100-PRO-07186005-S | Width 18 mm | In distribution |
| 100-PRO-08265510-S | Height 8 mm | In distribution |
| 100-PRO-13264505-S | Height 13 mm | In distribution |
| 100-PRO-06224525-S | Length 45 mm | In distribution |
| 100-PRO-14226005-S | Length 60 mm | In distribution |
| 100-PRO-06265505-S | Angle 5 ° | In distribution |
| 100-PRO-04184510-S | Angle 10 ° | In distribution |
| 100-PRO-12266015-S | Length 60 mm | In distribution |
| 100-PRO-10225510-S | Width 22 mm | In distribution |
| 100-PRO-14266010-S | Angle 10 ° | In distribution |
| 100-PRO-05226515-S | Height 5 mm | In distribution |
| 100-PRO-06185525-S | Length 55 mm | In distribution |
| 100-PRO-14186030-S | Angle 30 ° | In distribution |
| 100-PRO-08226025-S | Angle 25 ° | In distribution |
| 100-PRO-09184030-S | Length 40 mm | In distribution |
| 100-PRO-08164010-S | Length 40 mm | In distribution |
| 100-PRO-14264005-S | Angle 5 ° | In distribution |
| 100-PRO-11185500-S | Height 11 mm | In distribution |
| 100-PRO-10226010-S | Angle 10 ° | In distribution |
| 100-PRO-09184520-S | Angle 20 ° | In distribution |
| 100-PRO-12265010-S | Length 50 mm | In distribution |
| 100-PRO-08184000-S | Width 18 mm | In distribution |
| 100-PRO-07224505-S | Height 7 mm | In distribution |
| 100-PRO-12163500-S | Height 12 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 |
| 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.