IdentiTi

IdentiTi LIF-HL Porous Ti Spacer is a porous titanium interbody implant from Alphatec Spine’s IdentiTi family. It is placed in a lumbar disc space as a spacer and holds bone graft as part…

Registry build 21.09.26

IdentiTi LIF-HL Porous Ti Spacer is a porous titanium interbody implant from Alphatec Spine’s IdentiTi family. It is placed in a lumbar disc space as a spacer and holds bone graft as part of a spinal fusion construct.

The listed example is one geometry within the family. Other IdentiTi models vary by footprint, height and lordotic angle, so the family name alone does not define the dimensions of an individual spacer.

Listed Item

IDENTITi LIF-HL POROUS Ti SPACER, 10 x 22 x 40 mm, 30°

Implant Role

The spacer occupies the disc space and provides a structure around the bone graft within the fusion construct. It is one implant component in a procedure that may use separate supplemental fixation.

The listed device’s exact footprint, height and angle belong to its specific model identity. Model-level selection and fixation details follow the associated implant system labeling.

3manufacturers in China registered for this device type
1,372catalogue 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.

Chinese manufacturers registered for FDA product code OVD
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

Regulatory record for IdentiTi
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) K232097
Record published 2025-01-22
Record revised 2025-07-14 (version 3)

Specifications

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 Width 16 to 42 mm; height 4 to 16 mm; depth 22.5 to 70 mm; angle 5 to 30 °; length 22.5 to 70 mm; outer diameter 5 to 9 mm
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for IdentiTi
Catalogue number Size Status
232-13-80-375 Outer Diameter 8 mm In distribution
132-14382410-S Width 38 mm In distribution
232-14-80-350 Length 35 mm In distribution
232-10423015-S Width 42 mm In distribution
100-12184000-S Depth 40 mm In distribution
233-06342425 Angle 25 ° In distribution
255-10-13165500 Width 16 mm In distribution
255-12-09266005 Depth 60 mm In distribution
232-08423030-S Depth 30 mm In distribution
255-30-11186005 Height 11 mm In distribution
232-13-90-275 Outer Diameter 9 mm In distribution
233-06383210 Width 38 mm In distribution
233-10423015 Width 42 mm In distribution
255-12-10165010 Height 10 mm In distribution
132-08382830-S Width 38 mm In distribution
132-04423010-S Angle 10 ° In distribution
133-06342410 Width 34 mm In distribution
133-14382410 Height 14 mm In distribution
255-12-13266020 Angle 20 ° In distribution
132-06382410-S Height 6 mm In distribution
132-10-80-225 Outer Diameter 8 mm In distribution
133-14383215 Depth 32 mm In distribution
232-09382410-S Angle 10 ° In distribution
232-12382815-S Height 12 mm In distribution
133-10382420 Height 10 mm In distribution
232-13-85-400 Length 40 mm In distribution
133-07383210 Width 38 mm In distribution
233-04383215 Width 38 mm In distribution
233-06382420 Depth 24 mm In distribution
233-05342425 Width 34 mm In distribution
132-20-50-225 Depth 22.5 mm In distribution
232-10-80-300 Outer Diameter 8 mm In distribution
255-14-05186020 Angle 20 ° In distribution
113-14-10226015 Width 22 mm In distribution
132-11-90-325 Outer Diameter 9 mm In distribution
132-09423020-S Height 9 mm In distribution
233-08382420 Height 8 mm In distribution
113-10-04267010 Width 26 mm In distribution
255-30-09266030 Height 9 mm In distribution
132-11-80-250 Depth 25 mm In distribution
133-06382430 Angle 30 ° In distribution
133-13342410 Width 34 mm In distribution
233-06382430 Height 6 mm In distribution
233-07423020 Depth 30 mm In distribution
100-12224500-S Length 45 mm In distribution
132-09383210-S Width 38 mm In distribution
132-11423010-S Depth 30 mm In distribution
133-11383210 Height 11 mm In distribution
232-09342415-S Depth 24 mm In distribution
255-14-10226025 Width 22 mm In distribution
232-07423020-S Angle 20 ° In distribution
232-12423020-S Height 12 mm In distribution
255-10-07187015 Width 18 mm In distribution
132-11-85-300 Outer Diameter 8.5 mm In distribution
133-12342415 Height 12 mm In distribution
132-10-85-300 Depth 30 mm In distribution
255-14-05226025 Depth 60 mm In distribution
133-12382810 Depth 28 mm In distribution
132-10-80-400 Outer Diameter 8 mm In distribution
100-06264510-S Height 6 mm In distribution
132-08342415-S Depth 24 mm In distribution
232-07383215-S Width 38 mm In distribution
255-30-14226010 Height 14 mm In distribution
232-14383215-S Height 14 mm In distribution
232-05382820-S Angle 20 ° In distribution
133-07382825 Angle 25 ° In distribution
233-05383210 Angle 10 ° In distribution
132-20-50-400 Depth 40 mm In distribution
133-08382820 Depth 28 mm In distribution
233-08423010 Width 42 mm In distribution
132-10423015-S Width 42 mm In distribution
132-13423020-S Width 42 mm In distribution
255-14-05266015 Width 26 mm In distribution
233-13383210 Width 38 mm In distribution
232-12-60-225 Outer Diameter 6 mm In distribution
100-10224030-S Angle 30 ° In distribution
132-09383215-S Height 9 mm In distribution
113-12-08186015 Width 18 mm In distribution
255-14-07165010 Angle 10 ° In distribution
255-14-12186010 Depth 60 mm In distribution
132-12-50-250 Depth 25 mm In distribution
133-08382810 Height 8 mm In distribution
133-06382820 Depth 28 mm In distribution
232-07423010-S Angle 10 ° In distribution
233-04382820 Width 38 mm In distribution
132-05423020-S Width 42 mm In distribution
132-04342425-S Angle 25 ° In distribution
232-13383215-S Width 38 mm In distribution
255-12-12186030 Width 18 mm In distribution
113-12-06226015 Length 60 mm In distribution
133-04342415 Angle 15 ° In distribution
132-09423010-S Depth 30 mm In distribution
233-08382410 Height 8 mm In distribution
255-12-05226015 Height 5 mm In distribution
100-14184000-S Depth 40 mm In distribution
255-30-06266030 Angle 30 ° In distribution
113-12-08186000 Width 18 mm In distribution
232-14342420-S Depth 24 mm In distribution
100-07162500-S Width 16 mm In distribution
255-10-04187010 Depth 70 mm In distribution
132-05423030-S Height 5 mm In distribution
255-14-13266015 Depth 60 mm In distribution
132-14382820-S Height 14 mm In distribution
232-12-60-275 Outer Diameter 6 mm In distribution
232-06382830-S Height 6 mm In distribution
132-08423025-S Depth 30 mm In distribution
132-04382420-S Depth 24 mm In distribution
232-05342430-S Width 34 mm In distribution
132-06382810-S Height 6 mm In distribution
255-30-06186030 Height 6 mm In distribution
133-07383225 Height 7 mm In distribution
255-14-06186025 Depth 60 mm In distribution
233-11342420 Depth 24 mm In distribution
255-30-06186000 Height 6 mm In distribution
132-20-60-300 Depth 30 mm In distribution
132-20-60-275 Depth 27.5 mm In distribution
132-11-85-250 Depth 25 mm In distribution
255-14-09226005 Angle 5 ° In distribution
100-12184010-S Angle 10 ° In distribution
133-07423020 Depth 30 mm In distribution
133-10423010 Depth 30 mm In distribution
133-06423015 Height 6 mm In distribution
133-10342415 Width 34 mm In distribution
255-10-05267025 Height 5 mm In distribution
232-12-50-375 Length 37.5 mm In distribution
232-11382420-S Width 38 mm In distribution
232-06382810-S Width 38 mm In distribution
132-05342420-S Height 5 mm In distribution
232-06423025-S Depth 30 mm In distribution
133-06342415 Depth 24 mm In distribution
132-04382425-S Depth 24 mm In distribution
133-06382425 Depth 24 mm In distribution
233-06423010 Depth 30 mm In distribution
132-07342415-S Width 34 mm In distribution
132-11383215-S Height 11 mm In distribution
132-09342410-S Angle 10 ° In distribution
132-08423020-S Height 8 mm In distribution
132-06382825-S Width 38 mm In distribution
232-11423020-S Height 11 mm In distribution
232-13-85-250 Outer Diameter 8.5 mm In distribution
233-12342420 Angle 20 ° In distribution
255-10-13227015 Angle 15 ° In distribution
133-06383230 Width 38 mm In distribution
132-13342420-S Depth 24 mm In distribution
232-07382430-S Angle 30 ° In distribution
232-12342420-S Angle 20 ° In distribution
255-14-09266015 Angle 15 ° In distribution
255-30-14186020 Angle 20 ° In distribution
232-10-90-250 Length 25 mm In distribution
255-14-04186030 Angle 30 ° In distribution
232-04342415-S Angle 15 ° In distribution
232-13-80-300 Outer Diameter 8 mm In distribution
255-10-05227020 Height 5 mm In distribution
132-11382410-S Depth 24 mm In distribution
233-05423015 Angle 15 ° In distribution
233-14382415 Width 38 mm In distribution
133-07383215 Depth 32 mm In distribution
132-12382420-S Depth 24 mm In distribution
255-14-09186010 Width 18 mm In distribution
232-05423010-S Depth 30 mm In distribution
132-06342415-S Width 34 mm In distribution
232-06382420-S Width 38 mm In distribution
132-20-60-250 Depth 25 mm In distribution
255-14-04266025 Height 4 mm In distribution
232-10-90-225 Outer Diameter 9 mm In distribution
133-12383220 Width 38 mm In distribution
233-13382815 Width 38 mm In distribution
232-04383230-S Height 4 mm In distribution
233-05383230 Depth 32 mm In distribution
133-07382820 Angle 20 ° In distribution
133-09382810 Angle 10 ° In distribution
133-14382810 Height 14 mm In distribution
133-09382410 Angle 10 ° In distribution
232-10342415-S Depth 24 mm In distribution
132-07383220-S Depth 32 mm In distribution
232-08423025-S Depth 30 mm In distribution
132-11-85-375 Depth 37.5 mm In distribution
233-06383220 Width 38 mm In distribution
132-05382820-S Width 38 mm In distribution
232-04423010-S Width 42 mm In distribution
232-11383220-S Width 38 mm In distribution
255-14-11266005 Width 26 mm In distribution
255-30-04226015 Height 4 mm In distribution
100-07164010-S Width 16 mm In distribution
255-14-14266010 Depth 60 mm In distribution
133-07342410 Depth 24 mm In distribution
255-10-11267005 Depth 70 mm In distribution
100-10264010-S Angle 10 ° In distribution
132-07423010-S Depth 30 mm In distribution
255-10-08267025 Width 26 mm In distribution
232-11-90-375 Length 37.5 mm In distribution
132-10382410-S Width 38 mm In distribution
133-07382830 Depth 28 mm In distribution
255-14-13266005 Height 13 mm In distribution
113-10-14187000 Height 14 mm In distribution
232-06342410-S Width 34 mm In distribution
255-30-11186010 Depth 60 mm In distribution
232-11-85-375 Outer Diameter 8.5 mm In distribution
132-20-50-275 Depth 27.5 mm In distribution
233-10383210 Width 38 mm In distribution
255-30-11266015 Height 11 mm In distribution
133-08382420 Angle 20 ° In distribution
132-06382820-S Width 38 mm In distribution
233-06382810 Height 6 mm In distribution
255-10-15165500 Width 16 mm In distribution
100-12163010-S Height 12 mm In distribution
255-14-07226025 Depth 60 mm In distribution
232-13-85-375 Length 37.5 mm In distribution
255-10-04227020 Depth 70 mm In distribution
232-06383230-S Angle 30 ° In distribution
232-09383215-S Width 38 mm In distribution
113-10-08267010 Width 26 mm In distribution
255-14-10226020 Angle 20 ° In distribution
233-05382430 Depth 24 mm In distribution
233-10423020 Angle 20 ° In distribution
133-09382815 Width 38 mm In distribution
133-13382820 Height 13 mm In distribution
233-08383220 Height 8 mm In distribution
233-04382420 Depth 24 mm In distribution
233-08342420 Angle 20 ° In distribution
255-30-14226000 Depth 60 mm In distribution
133-11423015 Angle 15 ° In distribution
255-12-04266005 Depth 60 mm In distribution
232-13-90-400 Length 40 mm In distribution
232-08383230-S Width 38 mm In distribution
132-08382420-S Angle 20 ° In distribution
132-13383220-S Angle 20 ° In distribution
232-10382415-S Width 38 mm In distribution
100-06164000-S Width 16 mm In distribution
132-10-85-350 Depth 35 mm In distribution
232-12-50-225 Outer Diameter 5 mm In distribution
255-30-10266015 Width 26 mm In distribution
133-04383225 Depth 32 mm In distribution
100-06266000-S Height 6 mm In distribution
233-100 In distribution
132-14423010-S Depth 30 mm In distribution
132-04423025-S Height 4 mm In distribution
233-05383225 Width 38 mm In distribution
232-05423030-S Width 42 mm In distribution
232-05383210-S Width 38 mm In distribution
232-11-85-250 Outer Diameter 8.5 mm In distribution
232-14342410-S Depth 24 mm In distribution
255-10-12187010 Depth 70 mm In distribution
255-14-11186025 Angle 25 ° In distribution
132-12-60-225 Outer Diameter 6 mm In distribution
133-12342410 Depth 24 mm In distribution
255-12-12186000 Height 12 mm In distribution
233-13383220 Width 38 mm In distribution
133-06383210 Width 38 mm In distribution
132-10-85-250 Outer Diameter 8.5 mm In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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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
IDENTITi Nanotec Alphatec Spine, Inc. 453

Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K251575 2025-09-03
K232097 2023-09-25
K203742 2021-04-09
K123993 2013-03-05
K102402 2011-03-30

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of IdentiTi
Recalled by Identified by Initiated FDA class Root cause Reason Quantity
Alphatec Spine, Inc. 510(k) number 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer