IdentiTi II
ALIF SA BLADE INSERTER, 11-14 mm, DEPTH STOP
3manufacturers in China registered for this device type
60catalogue 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) | K242364 |
| Record published | 2026-02-18 |
| Record revised | 2025-07-14 (version 2) |
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 | Height 4 to 12 mm; width 16 to 38 mm; angle 10 to 25 °; length 25 to 65 mm; depth 24 to 28 mm; outer diameter 5 to 5.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 800-06224515-S | Height 6 mm | In distribution |
| 800-08185510-S | Length 55 mm | In distribution |
| 800-10185500-S | Length 55 mm | In distribution |
| 832-08342410-S | Width 34 mm | In distribution |
| 800-08185000-S | Height 8 mm | In distribution |
| 800-06186510-S | Length 65 mm | In distribution |
| 832-09342815-S | Height 9 mm | In distribution |
| 800-08224510-S | Length 45 mm | In distribution |
| 800-08185515-S | Angle 15 ° | In distribution |
| 832-04342420-S | Width 34 mm | In distribution |
| 834-0010 | In distribution | |
| 800-06163500-S | Width 16 mm | In distribution |
| 832-06342415-S | Depth 24 mm | In distribution |
| 832-11342815-S | Angle 15 ° | In distribution |
| 800-10224500-S | Height 10 mm | In distribution |
| 832-09382815-S | Depth 28 mm | In distribution |
| 800-08225510-S | Angle 10 ° | In distribution |
| 800-08225010-S | Angle 10 ° | In distribution |
| 832-09342810-S | Angle 10 ° | In distribution |
| 832-06382825-S | Height 6 mm | In distribution |
| 800-12185010-S | Angle 10 ° | In distribution |
| 832-1-50-400 | Length 45 mm | In distribution |
| 800-10225000-S | Height 10 mm | In distribution |
| 800-06185015-S | Angle 15 ° | In distribution |
| 834-2000 | In distribution | |
| 834-2010 | In distribution | |
| 800-08185500-S | Height 8 mm | In distribution |
| 800-08224515-S | Angle 15 ° | In distribution |
| 800-04224515-S | Angle 15 ° | In distribution |
| 832-12342410-S | Angle 10 ° | In distribution |
| 800-10184515-S | Height 10 mm | In distribution |
| 800-06225015-S | Height 6 mm | In distribution |
| 800-10186000-S | Height 10 mm | In distribution |
| 832-1-50-375 | Outer Diameter 5 mm | In distribution |
| 800-10185015-S | Angle 15 ° | In distribution |
| 832-07342425-S | Angle 25 ° | In distribution |
| 800-06186015-S | Width 18 mm | In distribution |
| 800-04186010-S | Height 4 mm | In distribution |
| 832-05342425-S | Angle 25 ° | In distribution |
| 800-06164000-S | Height 6 mm | In distribution |
| 832-05382815-S | Height 5 mm | In distribution |
| 800-08163500-S | Height 8 mm | In distribution |
| 800-08224500-S | Length 45 mm | In distribution |
| 800-10224510-S | Height 10 mm | In distribution |
| 834-2100 | In distribution | |
| 800-10226510-S | Angle 10 ° | In distribution |
| 832-1-55-275 | Outer Diameter 5.5 mm | In distribution |
| 800-10185000-S | Width 18 mm | In distribution |
| 832-04382820-S | Width 38 mm | In distribution |
| 832-08342420-S | Angle 20 ° | In distribution |
| 800-08186510-S | Length 65 mm | In distribution |
| 832-1-55-250 | Outer Diameter 5.5 mm | In distribution |
| 800-06224510-S | Height 6 mm | In distribution |
| 832-07382810-S | Width 38 mm | In distribution |
| 800-08164000-S | Width 16 mm | In distribution |
| 834-2001 | In distribution | |
| 832-04382825-S | Depth 28 mm | In distribution |
| 800-06185515-S | Angle 15 ° | In distribution |
| 832-11382815-S | Width 38 mm | In distribution |
| 800-10185010-S | Length 50 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.