IdentiTi
LIF Trial, Orientation, 12 x 22 x 70 mm, 10 Deg, Depth Markers
1manufacturer
940catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | PHM |
| Device type | Intervertebral Fusion Device With Bone Graft, Thoracic |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K183705 |
| Record published | 2020-10-20 |
| Record revised | 2025-07-14 (version 4) |
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 17 mm; width 9 to 42 mm; angle 5 to 30 °; length 22 to 70 mm; depth 12 to 70 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 123-13142505 | Height 13 mm | In distribution |
| 255-14-09226020 | Height 9 mm | In distribution |
| 123-11093015 | Width 9 mm | In distribution |
| 122-08102505-S | Width 10 mm | In distribution |
| 120-09092215-S | Width 9 mm | In distribution |
| 255-30-08226015 | Depth 60 mm | In distribution |
| 204-08382820-S | Height 8 mm | In distribution |
| 255-10-08187030 | Depth 70 mm | In distribution |
| 122-13122505-S | Length 25 mm | In distribution |
| 124-11102510-S | Width 10 mm | In distribution |
| 123-13094000 | Length 40 mm | In distribution |
| 123-15124005 | Length 40 mm | In distribution |
| 204-04382830-S | Width 38 mm | In distribution |
| 255-14-04226020 | Width 22 mm | In distribution |
| 255-30-11266010 | Height 11 mm | In distribution |
| 124-08103515-S | Angle 15 ° | In distribution |
| 122-14143010-S | Angle 10 ° | In distribution |
| 123-07122510 | Length 25 mm | In distribution |
| 100-10224015-S | Depth 40 mm | In distribution |
| 121-11092210 | Width 9 mm | In distribution |
| 130-04342420 | Angle 20 ° | In distribution |
| 123-12093000 | Length 30 mm | In distribution |
| 123-13144020 | Angle 20 ° | In distribution |
| 100-04226030-S | Angle 30 ° | In distribution |
| 255-14-06186005 | Height 6 mm | In distribution |
| 122-08093000-S | Height 8 mm | In distribution |
| 122-06143505-S | Height 6 mm | In distribution |
| 255-12-06186015 | Angle 15 ° | In distribution |
| 123-06142515 | Height 6 mm | In distribution |
| 113-12-04226020 | Angle 20 ° | In distribution |
| 124-11102515-S | Height 11 mm | In distribution |
| 123-10142515 | Length 25 mm | In distribution |
| 123-12123505 | Height 12 mm | In distribution |
| 255-12-13226010 | Width 22 mm | In distribution |
| 123-08123005 | Angle 5 ° | In distribution |
| 255-14-09226000 | Depth 60 mm | In distribution |
| 255-30-11186030 | Height 11 mm | In distribution |
| 205-07423020-S | Width 42 mm | In distribution |
| 100-08226015-S | Length 60 mm | In distribution |
| 255-12-12186015 | Width 18 mm | In distribution |
| 205-04342415-S | Depth 24 mm | In distribution |
| 122-16123510-S | Height 16 mm | In distribution |
| 100-06186000-S | Depth 60 mm | In distribution |
| 122-09143015-S | Width 14 mm | In distribution |
| 123-08142520 | Length 25 mm | In distribution |
| 100-04224515-S | Height 4 mm | In distribution |
| 129-06382820-S | Height 6 mm | In distribution |
| 124-13103510-S | Height 13 mm | In distribution |
| 122-11143505-S | Width 14 mm | In distribution |
| 100-06163500-S | Width 16 mm | In distribution |
| 120-13093005-S | Angle 5 ° | In distribution |
| 94037-003-S | Angle 5 ° | In distribution |
| 122-08122505-S | Length 25 mm | In distribution |
| 124-12102510-S | Angle 10 ° | In distribution |
| 123-13122505 | Length 25 mm | In distribution |
| 121-09092505 | Angle 5 ° | In distribution |
| 255-14-11226010 | Depth 60 mm | In distribution |
| 114-11382815 | Length 28 mm | In distribution |
| 100-12226000-S | Length 60 mm | In distribution |
| 204-06342415-S | Depth 24 mm | In distribution |
| 105-05382810-S | Width 38 mm | In distribution |
| 205-08342410-S | Angle 10 ° | In distribution |
| 122-10103515-S | Angle 15 ° | In distribution |
| 123-15142500 | Height 15 mm | In distribution |
| 123-06124010 | Height 6 mm | In distribution |
| 205-05382815-S | Angle 15 ° | In distribution |
| 122-14123510-S | Angle 10 ° | In distribution |
| 255-14-11266015 | Angle 15 ° | In distribution |
| 130-05382810 | Width 38 mm | In distribution |
| 100-06185510-S | Length 55 mm | In distribution |
| 124-09103010-S | Angle 10 ° | In distribution |
| 121-100-50 | In distribution | |
| 123-14123005 | Length 30 mm | In distribution |
| 123-12092500 | Length 25 mm | In distribution |
| 100-10185500-S | Length 55 mm | In distribution |
| 255-10-07187010 | Height 7 mm | In distribution |
| 122-09123510-S | Height 9 mm | In distribution |
| 94037-173-S | Angle 5 ° | In distribution |
| 124-07103515-S | Angle 15 ° | In distribution |
| 123-11143015 | Width 14 mm | In distribution |
| 123-10092500 | Width 9 mm | In distribution |
| 123-06144015 | Angle 15 ° | In distribution |
| 123-11143010 | Length 30 mm | In distribution |
| 113-12-08266010 | Height 8 mm | In distribution |
| 255-10-07165500 | Width 16 mm | In distribution |
| 114-07382815 | Height 7 mm | In distribution |
| 123-12102505 | Length 25 mm | In distribution |
| 122-10123015-S | Length 30 mm | In distribution |
| 113-14-06186010 | Width 18 mm | In distribution |
| 130-09382815 | Height 9 mm | In distribution |
| 255-10-12227010 | Depth 70 mm | In distribution |
| 255-14-06226025 | Height 6 mm | In distribution |
| 100-04226020-S | Width 22 mm | In distribution |
| 123-09124010 | Angle 10 ° | In distribution |
| 255-12-04266020 | Height 4 mm | In distribution |
| 255-14-06186020 | Angle 20 ° | In distribution |
| 121-13092220 | Angle 20 ° | In distribution |
| 255-10-16267000 | Depth 70 mm | In distribution |
| 255-30-09266010 | Width 26 mm | In distribution |
| CI-10309 | In distribution | |
| 123-12123005 | Angle 5 ° | In distribution |
| 122-11092505-S | Length 25 mm | In distribution |
| 122-06102510-S | Width 10 mm | In distribution |
| 123-12093010 | Width 9 mm | In distribution |
| 255-12-13226025 | Depth 60 mm | In distribution |
| 123-09144000 | Height 9 mm | In distribution |
| 120-08092505-S | Width 9 mm | In distribution |
| 121-08092215 | Height 8 mm | In distribution |
| 255-12-08266010 | Width 26 mm | In distribution |
| 122-06123005-S | Length 30 mm | In distribution |
| 122-09143510-S | Angle 10 ° | In distribution |
| 123-11143505 | Length 35 mm | In distribution |
| 113-12-04226015 | Length 60 mm | In distribution |
| 122-11103505-S | Width 10 mm | In distribution |
| 100-08266010-S | Angle 10 ° | In distribution |
| 255-30-06266020 | Angle 20 ° | In distribution |
| 122-07122510-S | Width 12 mm | In distribution |
| 255-12-04226020 | Depth 60 mm | In distribution |
| 255-10-10267005 | Height 10 mm | In distribution |
| 124-07103015-S | Width 10 mm | In distribution |
| 122-08143505-S | Width 14 mm | In distribution |
| 122-09093010-S | Angle 10 ° | In distribution |
| 255-12-13165010 | Depth 50 mm | In distribution |
| 94037-001-S | Height 8 mm | In distribution |
| 255-10-05187020 | Height 5 mm | In distribution |
| 123-06093515 | Height 6 mm | In distribution |
| 123-09094010 | Height 9 mm | In distribution |
| 122-06103005-S | Height 6 mm | In distribution |
| 255-30-08266015 | Width 26 mm | In distribution |
| 122-10103510-S | Length 35 mm | In distribution |
| 122-14143005-S | Length 30 mm | In distribution |
| 121-09092510 | Height 9 mm | In distribution |
| 255-30-05226010 | Angle 10 ° | In distribution |
| 114-10342415 | Height 10 mm | In distribution |
| 205-04342430-S | Depth 24 mm | In distribution |
| 255-30-10266010 | Depth 60 mm | In distribution |
| 204-08342420-S | Height 8 mm | In distribution |
| 122-09103015-S | Angle 15 ° | In distribution |
| 122-12122505-S | Height 12 mm | In distribution |
| 123-09122520 | Width 12 mm | In distribution |
| 123-06102510 | Height 6 mm | In distribution |
| 100-08265010-S | Angle 10 ° | In distribution |
| 123-13142510 | Length 25 mm | In distribution |
| 123-13142515 | Angle 15 ° | In distribution |
| 123-10122500 | Height 10 mm | In distribution |
| 113-14-08226020 | Length 60 mm | In distribution |
| 255-30-11186000 | Width 18 mm | In distribution |
| 123-08124015 | Length 40 mm | In distribution |
| 130-11382810 | Angle 10 ° | In distribution |
| 100-12264510-S | Length 50 mm | In distribution |
| 122-09093005-S | Height 9 mm | In distribution |
| 122-06093005-S | Width 9 mm | In distribution |
| 125-12102515 | Width 10 mm | In distribution |
| 255-12-06226005 | Height 6 mm | In distribution |
| 123-06143010 | Height 6 mm | In distribution |
| 122-08103505-S | Angle 5 ° | In distribution |
| 255-12-06186000 | Depth 60 mm | In distribution |
| 255-30-09226020 | Width 22 mm | In distribution |
| 120-12092505-S | Angle 5 ° | In distribution |
| 100-08225020-S | Angle 20 ° | In distribution |
| 255-12-09226005 | Depth 60 mm | In distribution |
| 255-14-14186005 | Width 18 mm | In distribution |
| 123-10093515 | Width 9 mm | In distribution |
| 123-10144020 | Width 14 mm | In distribution |
| 129-05382810-S | Width 38 mm | In distribution |
| 124-09102505-S | Height 9 mm | In distribution |
| 255-12-16165010 | Width 16 mm | In distribution |
| 123-08093510 | Width 9 mm | In distribution |
| 255-14-04186015 | Width 18 mm | In distribution |
| 122-07123500-S | Height 7 mm | In distribution |
| 122-07122515-S | Height 7 mm | In distribution |
| 100-08225000-S | Height 8 mm | In distribution |
| 122-16093010-S | Height 16 mm | In distribution |
| 122-13143505-S | Length 35 mm | In distribution |
| 130-06342430 | Height 6 mm | In distribution |
| 122-07103015-S | Angle 15 ° | In distribution |
| 122-14122515-S | Width 12 mm | In distribution |
| 113-12-14186000 | Height 14 mm | In distribution |
| 255-30-12186025 | Width 18 mm | In distribution |
| 123-13092515 | Height 13 mm | In distribution |
| 123-10144005 | Angle 5 ° | In distribution |
| 255-30-14266020 | Height 14 mm | In distribution |
| 122-09102505-S | Length 25 mm | In distribution |
| 122-14103010-S | Height 14 mm | In distribution |
| 124-10103010-S | Angle 10 ° | In distribution |
| 255-30-04226010 | Angle 10 ° | In distribution |
| 100-09164500-S | Width 16 mm | In distribution |
| 123-13123515 | Length 35 mm | In distribution |
| 122-11093010-S | Height 11 mm | In distribution |
| 122-08123505-S | Angle 5 ° | In distribution |
| 255-14-04266030 | Angle 30 ° | In distribution |
| 123-12092515 | Angle 15 ° | In distribution |
| 122-11143015-S | Height 11 mm | In distribution |
| 255-12-13186000 | Height 13 mm | In distribution |
| 123-10102505 | Width 10 mm | In distribution |
| 123-07093515 | Length 35 mm | In distribution |
| 123-10143505 | Height 10 mm | In distribution |
| 100-10224515-S | Height 10 mm | In distribution |
| 123-12142520 | Length 25 mm | In distribution |
| 121-14092205 | Width 9 mm | In distribution |
| 123-13123005 | Height 13 mm | In distribution |
| 123-12122505 | Angle 5 ° | In distribution |
| 123-08092515 | Angle 15 ° | In distribution |
| 123-13124015 | Length 40 mm | In distribution |
| 255-14-14186010 | Depth 60 mm | In distribution |
| 255-30-11226030 | Depth 60 mm | In distribution |
| 255-14-10186005 | Depth 60 mm | In distribution |
| 255-14-08226010 | Width 22 mm | In distribution |
| 123-11092520 | Length 25 mm | In distribution |
| 123-11143500 | Height 11 mm | In distribution |
| 123-06093010 | Height 6 mm | In distribution |
| 114-06342415 | Angle 15 ° | In distribution |
| 123-07143000 | Length 30 mm | In distribution |
| 255-12-10226030 | Width 22 mm | In distribution |
| 255-14-09165000 | Width 16 mm | In distribution |
| 123-10124015 | Height 10 mm | In distribution |
| 124-11103510-S | Length 35 mm | In distribution |
| 123-16143000 | Height 16 mm | In distribution |
| 123-11124010 | Width 12 mm | In distribution |
| 255-10-10227010 | Depth 70 mm | In distribution |
| 255-10-11187015 | Depth 70 mm | In distribution |
| 123-13124000 | Height 13 mm | In distribution |
| 122-13092505-S | Angle 5 ° | In distribution |
| 205-07382810-S | Width 38 mm | In distribution |
| 113-90-06165500 | Depth 55 mm | In distribution |
| 123-13093500 | Length 35 mm | In distribution |
| 123-13144005 | Height 13 mm | In distribution |
| 123-11142500 | Width 14 mm | In distribution |
| 122-15143515-S | Angle 15 ° | In distribution |
| 204-10342420-S | Width 34 mm | In distribution |
| 125-14102510 | Height 14 mm | In distribution |
| 100-14184500-S | Height 14 mm | In distribution |
| 204-05382810-S | Angle 10 ° | In distribution |
| 204-07382810-S | Depth 28 mm | In distribution |
| 113-10-10227015 | Angle 15 ° | In distribution |
| 123-12122510 | Height 12 mm | In distribution |
| 123-15122505 | Length 25 mm | In distribution |
| 122-14093005-S | Width 9 mm | In distribution |
| 255-30-08186020 | Height 8 mm | In distribution |
| 123-12143520 | Height 12 mm | In distribution |
| 122-10122510-S | Angle 10 ° | In distribution |
| CI-10392-12-04226015 | Depth 60 mm | In distribution |
| 123-10092505 | Length 25 mm | In distribution |
| 255-30-09266025 | Depth 60 mm | In distribution |
| 100-08225030-S | Angle 30 ° | In distribution |
| 123-07093020 | Height 7 mm | In distribution |
| 100-06184015-S | Height 6 mm | In distribution |
| 122-15123015-S | Angle 15 ° | In distribution |
| 255-14-10266025 | Depth 60 mm | In distribution |
| 123-09093000 | Width 9 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 2,299 |
| Solar™ Interbody Fusion System | Degen Medical | 805 |
| Transcend Nanotec | Alphatec Spine, Inc. | 466 |
| IDENTITi Nanotec | Alphatec Spine, Inc. | 459 |
| E3D-A Interbody System | Evolution Spine, LLC | 308 |
| Battalion | Alphatec Spine, Inc. | 241 |
| Reef L | Seaspine Orthopedics Corporation | 207 |
| IdentiTi II | Alphatec Spine, Inc. | 163 |
| Modulus | Nuvasive, Inc. | 158 |
| Hedron | Globus Medical, Inc. | 156 |
| Roccia | Silony Medical Gmbh | 133 |
| TLX | Nuvasive, Inc. | 88 |
Showing 12 of 41. All products under Intervertebral Fusion Device With Bone Graft, Thoracic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180480 | 2018-05-31 |
| K160958 | 2016-09-08 |
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.