IdentiTi II
IDENTITI-II PC, TRIAL, 12 x 10 x 25mm, 15°
1manufacturer
163catalogue 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) | K242364 |
| Record published | 2025-03-20 |
| 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 16 mm; width 10 to 22 mm; length 25 to 65 mm; angle 5 to 20 ° |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 801-100 | In distribution | |
| 823-12102515 | Angle 15 ° | In distribution |
| 800-04185515-S | Height 4 mm | In distribution |
| 822-11123515-S | Height 11 mm | In distribution |
| 823-06103010 | Height 6 mm | In distribution |
| 823-08103510 | Width 10 mm | In distribution |
| 823-12104020 | Height 12 mm | In distribution |
| 823-13104005 | Width 10 mm | In distribution |
| 823-12104015 | Width 10 mm | In distribution |
| 800-10186510-S | Angle 10 ° | In distribution |
| 800-04184510-S | Height 4 mm | In distribution |
| 800-06226015-S | Width 22 mm | In distribution |
| 822-07103515-S | Length 35 mm | In distribution |
| 822-10103015-S | Width 10 mm | In distribution |
| 823-11102510 | Length 25 mm | In distribution |
| 823-11103005 | Length 30 mm | In distribution |
| 822-11104005-S | Height 11 mm | In distribution |
| 823-15103015 | Height 15 mm | In distribution |
| 822-10103515-S | Length 35 mm | In distribution |
| 822-07123515-S | Height 7 mm | In distribution |
| 801-200 | In distribution | |
| 800-04226010-S | Width 22 mm | In distribution |
| 823-16104020 | Height 16 mm | In distribution |
| 823-11103015 | Width 10 mm | In distribution |
| 822-11144015-S | Height 11 mm | In distribution |
| 823-101 | In distribution | |
| 823-06104020 | Angle 20 ° | In distribution |
| 823-06103510 | Angle 10 ° | In distribution |
| 823-15102520 | Height 15 mm | In distribution |
| 800-10184500-S | Height 10 mm | In distribution |
| 823-11102520 | Length 25 mm | In distribution |
| 823-16104005 | Length 40 mm | In distribution |
| 823-07103515 | Length 35 mm | In distribution |
| 800-08226010-S | Angle 10 ° | In distribution |
| 823-08103010 | Width 10 mm | In distribution |
| 823-11104010 | Length 40 mm | In distribution |
| 822-08144015-S | Length 40 mm | In distribution |
| 823-15104010 | Angle 10 ° | In distribution |
| 822-09123515-S | Width 10 mm | In distribution |
| 823-08103005 | Angle 5 ° | In distribution |
| 823-07102520 | Height 7 mm | In distribution |
| 822-12104005-S | Width 10 mm | In distribution |
| 823-12102510 | Height 12 mm | In distribution |
| 823-10103015 | Width 10 mm | In distribution |
| 800-10225515-S | Angle 15 ° | In distribution |
| 823-13103015 | Width 10 mm | In distribution |
| 823-15102510 | Length 25 mm | In distribution |
| 823-16103515 | Height 16 mm | In distribution |
| 823-15102505 | Angle 5 ° | In distribution |
| 823-08104020 | Height 8 mm | In distribution |
| 800-08185015-S | Height 8 mm | In distribution |
| 822-06103510-S | Width 10 mm | In distribution |
| 823-06104005 | Height 6 mm | In distribution |
| 823-08103020 | Width 10 mm | In distribution |
| 823-10103510 | Angle 10 ° | In distribution |
| 822-11103510-S | Length 35 mm | In distribution |
| 822-12103010-S | Length 30 mm | In distribution |
| 823-09104020 | Height 9 mm | In distribution |
| 822-10123515-S | Length 35 mm | In distribution |
| 823-06102510 | Length 25 mm | In distribution |
| 823-16103005 | Length 30 mm | In distribution |
| 822-08103005-S | Length 30 mm | In distribution |
| 823-06102505 | Angle 5 ° | In distribution |
| 823-14104010 | Angle 10 ° | In distribution |
| 800-08184500-S | Length 45 mm | In distribution |
| 823-14104020 | Width 10 mm | In distribution |
| 801-140 | In distribution | |
| 823-10104010 | Length 40 mm | In distribution |
| 800-10185515-S | Angle 15 ° | In distribution |
| 800-08225500-S | Length 55 mm | In distribution |
| 823-10103005 | Width 10 mm | In distribution |
| 822-08103020-S | Angle 20 ° | In distribution |
| 823-11103020 | Length 30 mm | In distribution |
| 800-10226015-S | Angle 15 ° | In distribution |
| 823-14103005 | Height 14 mm | In distribution |
| 823-15103510 | Width 10 mm | In distribution |
| 823-14102520 | Length 25 mm | In distribution |
| 823-16104015 | Width 10 mm | In distribution |
| 823-12103505 | Angle 5 ° | In distribution |
| 823-10103010 | Width 10 mm | In distribution |
| 822-08102505-S | Length 25 mm | In distribution |
| 823-07103010 | Height 7 mm | In distribution |
| 823-09103005 | Angle 5 ° | In distribution |
| 800-10226010-S | Height 10 mm | In distribution |
| 822-10102505-S | Angle 5 ° | In distribution |
| 823-16103015 | Length 30 mm | In distribution |
| 801-100-50 | In distribution | |
| 823-15104015 | Height 15 mm | In distribution |
| 823-06103005 | Width 10 mm | In distribution |
| 801-240-50 | In distribution | |
| 800-08226000-S | Length 60 mm | In distribution |
| 823-09103520 | Width 10 mm | In distribution |
| 823-15102515 | Height 15 mm | In distribution |
| 822-10103020-S | Height 10 mm | In distribution |
| 822-08103015-S | Angle 15 ° | In distribution |
| 823-15103515 | Width 10 mm | In distribution |
| 823-06102520 | Height 6 mm | In distribution |
| 800-12185500-S | Length 55 mm | In distribution |
| 800-12226010-S | Length 60 mm | In distribution |
| 823-08102520 | Height 8 mm | In distribution |
| 823-15103010 | Width 10 mm | In distribution |
| 822-12103510-S | Height 12 mm | In distribution |
| 823-12103010 | Height 12 mm | In distribution |
| 822-07104005-S | Length 40 mm | In distribution |
| 822-08104005-S | Width 10 mm | In distribution |
| 823-15103520 | Width 10 mm | In distribution |
| 823-12104010 | Height 12 mm | In distribution |
| 823-13102510 | Height 13 mm | In distribution |
| 823-07104010 | Length 40 mm | In distribution |
| 822-10103005-S | Height 10 mm | In distribution |
| 800-12225500-S | Width 22 mm | In distribution |
| 823-12103520 | Width 10 mm | In distribution |
| 823-14103505 | Width 10 mm | In distribution |
| 822-06103020-S | Width 10 mm | In distribution |
| 823-10102515 | Angle 15 ° | In distribution |
| 822-13103010-S | Height 13 mm | In distribution |
| 800-04185010-S | Angle 10 ° | In distribution |
| 823-12103515 | Length 35 mm | In distribution |
| 823-06103520 | Width 10 mm | In distribution |
| 823-13102515 | Angle 15 ° | In distribution |
| 823-08103515 | Height 8 mm | In distribution |
| 800-12225510-S | Width 22 mm | In distribution |
| 823-12103005 | Height 12 mm | In distribution |
| 822-11103015-S | Width 10 mm | In distribution |
| 823-09103010 | Width 10 mm | In distribution |
| 823-07103520 | Length 35 mm | In distribution |
| 823-13104010 | Height 13 mm | In distribution |
| 823-15103005 | Width 10 mm | In distribution |
| 822-08103510-S | Length 35 mm | In distribution |
| 823-10104020 | Width 10 mm | In distribution |
| 823-07103020 | Angle 20 ° | In distribution |
| 822-06144015-S | Angle 15 ° | In distribution |
| 823-12102520 | Angle 20 ° | In distribution |
| 823-10103505 | Height 10 mm | In distribution |
| 823-06103015 | Angle 15 ° | In distribution |
| 823-06103020 | Width 10 mm | In distribution |
| 823-11102515 | Height 11 mm | In distribution |
| 800-10225010-S | Width 22 mm | In distribution |
| 801-220-50 | In distribution | |
| 823-09103505 | Angle 5 ° | In distribution |
| 823-14104005 | Length 40 mm | In distribution |
| 823-14103510 | Height 14 mm | In distribution |
| 822-12103005-S | Width 10 mm | In distribution |
| 822-09102505-S | Angle 5 ° | In distribution |
| 823-12102505 | Length 25 mm | In distribution |
| 800-04225515-S | Angle 15 ° | In distribution |
| 823-07103005 | Height 7 mm | In distribution |
| 822-06102505-S | Length 25 mm | In distribution |
| 800-10225510-S | Length 55 mm | In distribution |
| 800-08186010-S | Length 60 mm | In distribution |
| 800-08226015-S | Length 60 mm | In distribution |
| 823-09102510 | Length 25 mm | In distribution |
| 823-13103520 | Height 13 mm | In distribution |
| 800-10225500-S | Width 22 mm | In distribution |
| 800-08184515-S | Angle 15 ° | In distribution |
| 822-10103510-S | Width 10 mm | In distribution |
| 800-08225515-S | Length 55 mm | In distribution |
| 800-04226015-S | Length 60 mm | In distribution |
| 823-14103015 | Length 30 mm | In distribution |
| 823-14103020 | Height 14 mm | In distribution |
| 823-11103510 | Width 10 mm | In distribution |
| 823-06104010 | Height 6 mm | In distribution |
| 823-06104015 | Angle 15 ° | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 2,299 |
| IdentiTi | Alphatec Spine, Inc. | 940 |
| 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 |
| 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.