IDENTITi Nanotec
IDENTITi NANOTEC LIF-HL POROUS Ti SPACER, 10 x 18 x 55 mm, 20°
1manufacturer
459catalogue 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) | K211805 |
| Record published | 2021-12-29 |
| Record revised | 2025-07-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| 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 9 to 26 mm; height 4 to 16 mm; length 25 to 65 mm; angle 5 to 30 °; depth 22 to 35 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100-PRO-04225010-S | Width 22 mm | In distribution |
| 100-PRO-07224000-S | Height 7 mm | In distribution |
| 100-PRO-10185520-S | Length 55 mm | In distribution |
| 100-PRO-04186515-S | Angle 15 ° | In distribution |
| 100-PRO-05266030-S | Width 26 mm | In distribution |
| 100-PRO-10186005-S | Angle 5 ° | In distribution |
| 100-PRO-13184505-S | Angle 5 ° | In distribution |
| 100-PRO-13184020-S | Angle 20 ° | In distribution |
| 100-PRO-09185030-S | Width 18 mm | In distribution |
| 100-PRO-11265515-S | Length 55 mm | In distribution |
| 100-PRO-04225020-S | Length 50 mm | In distribution |
| 100-PRO-10186515-S | Length 65 mm | In distribution |
| 100-PRO-11184030-S | Length 40 mm | In distribution |
| 100-PRO-10186505-S | Height 10 mm | In distribution |
| 100-PRO-05185525-S | Width 18 mm | In distribution |
| 100-PRO-16265500-S | Width 26 mm | In distribution |
| 100-PRO-07184525-S | Length 45 mm | In distribution |
| 100-PRO-15226500-S | Width 22 mm | In distribution |
| 124-PRO-14103005-S | Angle 5 ° | In distribution |
| 100-PRO-09186015-S | Width 18 mm | In distribution |
| 100-PRO-07164500-S | Height 7 mm | In distribution |
| 100-PRO-12185015-S | Length 50 mm | In distribution |
| 100-PRO-13186520-S | Angle 20 ° | In distribution |
| 100-PRO-04264505-S | Height 4 mm | In distribution |
| 100-PRO-06226500-S | Width 22 mm | In distribution |
| 124-PRO-09102510-S | Width 10 mm | In distribution |
| 100-PRO-14266520-S | Height 14 mm | In distribution |
| 100-PRO-06264515-S | Length 45 mm | In distribution |
| 100-PRO-07226525-S | Length 65 mm | In distribution |
| 100-PRO-14185510-S | Width 18 mm | In distribution |
| 100-PRO-13224000-S | Height 13 mm | In distribution |
| 100-PRO-04184030-S | Length 40 mm | In distribution |
| 100-PRO-12225510-S | Width 22 mm | In distribution |
| 100-PRO-06264010-S | Height 6 mm | In distribution |
| 100-PRO-05224510-S | Length 45 mm | In distribution |
| 100-PRO-05265020-S | Width 26 mm | In distribution |
| 124-PRO-10102510-S | Angle 10 ° | In distribution |
| 100-PRO-09265010-S | Length 50 mm | In distribution |
| 100-PRO-10184025-S | Length 40 mm | In distribution |
| 100-PRO-10225500-S | Width 22 mm | In distribution |
| 100-PRO-07184530-S | Width 18 mm | In distribution |
| 100-PRO-10224530-S | Length 45 mm | In distribution |
| 100-PRO-09185520-S | Height 9 mm | In distribution |
| 100-PRO-14186005-S | Height 14 mm | In distribution |
| 100-PRO-09225030-S | Length 50 mm | In distribution |
| 100-PRO-08185015-S | Angle 15 ° | In distribution |
| 100-PRO-06266010-S | Width 26 mm | In distribution |
| 120-PRO-09092210-S | Height 9 mm | In distribution |
| 100-PRO-09164010-S | Width 16 mm | In distribution |
| 100-PRO-16265000-S | Width 26 mm | In distribution |
| 124-PRO-15103005-S | Depth 30 mm | In distribution |
| 100-PRO-06266510-S | Angle 10 ° | In distribution |
| 100-PRO-12224000-S | Width 22 mm | In distribution |
| 100-PRO-12266520-S | Length 65 mm | In distribution |
| 100-PRO-14226000-S | Height 14 mm | In distribution |
| 100-PRO-08185525-S | Angle 25 ° | In distribution |
| 100-PRO-04265510-S | Angle 10 ° | In distribution |
| 100-PRO-05265010-S | Angle 10 ° | In distribution |
| 120-PRO-08093005-S | Height 8 mm | In distribution |
| 100-PRO-14225010-S | Width 22 mm | In distribution |
| 100-PRO-04224010-S | Height 4 mm | In distribution |
| 100-PRO-13225000-S | Height 13 mm | In distribution |
| 100-PRO-06225525-S | Length 55 mm | In distribution |
| 100-PRO-10224505-S | Length 45 mm | In distribution |
| 100-PRO-12186030-S | Width 18 mm | In distribution |
| 100-PRO-13265510-S | Length 55 mm | In distribution |
| 100-PRO-10186020-S | Height 10 mm | In distribution |
| 100-PRO-14266515-S | Length 65 mm | In distribution |
| 100-PRO-04265020-S | Width 26 mm | In distribution |
| 100-PRO-13266015-S | Length 60 mm | In distribution |
| 100-PRO-16266000-S | Length 60 mm | In distribution |
| 100-PRO-07186510-S | Length 65 mm | In distribution |
| 100-PRO-05226010-S | Angle 10 ° | In distribution |
| 100-PRO-16266500-S | Length 65 mm | In distribution |
| 100-PRO-06184520-S | Angle 20 ° | In distribution |
| 100-PRO-10266505-S | Length 65 mm | In distribution |
| 100-PRO-08264005-S | Height 8 mm | In distribution |
| 100-PRO-13225500-S | Height 13 mm | In distribution |
| 100-PRO-09224505-S | Length 45 mm | In distribution |
| 100-PRO-08225000-S | Height 8 mm | In distribution |
| 100-PRO-08226510-S | Width 22 mm | In distribution |
| 100-PRO-07226500-S | Width 22 mm | In distribution |
| 100-PRO-11265015-S | Width 26 mm | In distribution |
| 100-PRO-06266520-S | Length 65 mm | In distribution |
| 100-PRO-13225025-S | Height 13 mm | In distribution |
| 100-PRO-11184015-S | Width 18 mm | In distribution |
| 100-PRO-06265010-S | Width 26 mm | In distribution |
| 100-PRO-07186020-S | Width 18 mm | In distribution |
| 100-PRO-07266030-S | Length 60 mm | In distribution |
| 100-PRO-10224500-S | Height 10 mm | In distribution |
| 100-PRO-13184500-S | Height 13 mm | In distribution |
| 100-PRO-04185010-S | Angle 10 ° | In distribution |
| 100-PRO-06185030-S | Angle 30 ° | In distribution |
| 100-PRO-12163010-S | Height 12 mm | In distribution |
| 100-PRO-04224505-S | Length 45 mm | In distribution |
| 100-PRO-11224005-S | Length 40 mm | In distribution |
| 100-PRO-09225530-S | Angle 30 ° | In distribution |
| 100-PRO-06264005-S | Width 26 mm | In distribution |
| 100-PRO-11266000-S | Height 11 mm | In distribution |
| 124-PRO-15103010-S | Width 10 mm | In distribution |
| 124-PRO-08103010-S | Width 10 mm | In distribution |
| 100-PRO-12265515-S | Length 55 mm | In distribution |
| 100-PRO-06264020-S | Length 40 mm | In distribution |
| 100-PRO-15225500-S | Height 15 mm | In distribution |
| 100-PRO-05266005-S | Height 5 mm | In distribution |
| 120-PRO-10093005-S | Depth 30 mm | In distribution |
| 100-PRO-08266505-S | Height 8 mm | In distribution |
| 124-PRO-13103010-S | Height 13 mm | In distribution |
| 100-PRO-07185510-S | Height 7 mm | In distribution |
| 100-PRO-11163010-S | Height 11 mm | In distribution |
| 100-PRO-05266505-S | Length 65 mm | In distribution |
| 100-PRO-11185025-S | Angle 25 ° | In distribution |
| 120-PRO-12093005-S | Angle 5 ° | In distribution |
| 100-PRO-06186530-S | Height 6 mm | In distribution |
| 100-PRO-10226510-S | Angle 10 ° | In distribution |
| 100-PRO-13224010-S | Width 22 mm | In distribution |
| 100-PRO-14264505-S | Width 26 mm | In distribution |
| 124-PRO-08103515-S | Height 8 mm | In distribution |
| 100-PRO-11265010-S | Length 50 mm | In distribution |
| 120-PRO-09092205-S | Depth 22 mm | In distribution |
| 100-PRO-04225525-S | Length 55 mm | In distribution |
| 100-PRO-05186030-S | Width 18 mm | In distribution |
| 100-PRO-11224505-S | Length 45 mm | In distribution |
| 100-PRO-13186020-S | Height 13 mm | In distribution |
| 100-PRO-12186020-S | Height 12 mm | In distribution |
| 100-PRO-04224020-S | Height 4 mm | In distribution |
| 100-PRO-13266515-S | Height 13 mm | In distribution |
| 100-PRO-10266025-S | Angle 25 ° | In distribution |
| 100-PRO-12186515-S | Angle 15 ° | In distribution |
| 100-PRO-07184015-S | Width 18 mm | In distribution |
| 100-PRO-11225000-S | Width 22 mm | In distribution |
| 100-PRO-12226025-S | Height 12 mm | In distribution |
| 100-PRO-08225510-S | Width 22 mm | In distribution |
| 100-PRO-04224510-S | Width 22 mm | In distribution |
| 100-PRO-09265505-S | Width 26 mm | In distribution |
| 100-PRO-05186525-S | Height 5 mm | In distribution |
| 100-PRO-09265015-S | Length 50 mm | In distribution |
| 100-PRO-04226530-S | Width 22 mm | In distribution |
| 100-PRO-08225515-S | Height 8 mm | In distribution |
| 100-PRO-09264000-S | Width 26 mm | In distribution |
| 100-PRO-05224030-S | Width 22 mm | In distribution |
| 120-PRO-13093010-S | Height 13 mm | In distribution |
| 124-PRO-13102505-S | Width 10 mm | In distribution |
| 100-PRO-07264030-S | Height 7 mm | In distribution |
| 100-PRO-05185520-S | Width 18 mm | In distribution |
| 100-PRO-07225010-S | Angle 10 ° | In distribution |
| 100-PRO-07266015-S | Width 26 mm | In distribution |
| 100-PRO-12224510-S | Height 12 mm | In distribution |
| 100-PRO-09184525-S | Length 45 mm | In distribution |
| 100-PRO-09186025-S | Length 60 mm | In distribution |
| 120-PRO-13093015-S | Depth 30 mm | In distribution |
| 100-PRO-09266525-S | Length 65 mm | In distribution |
| 124-PRO-10103515-S | Angle 15 ° | In distribution |
| 100-PRO-10265010-S | Height 10 mm | In distribution |
| 100-PRO-08185505-S | Length 55 mm | In distribution |
| 100-PRO-10185015-S | Width 18 mm | In distribution |
| 100-PRO-14184500-S | Width 18 mm | In distribution |
| 100-PRO-05266020-S | Height 5 mm | In distribution |
| 100-PRO-09265020-S | Angle 20 ° | In distribution |
| 100-PRO-07186515-S | Height 7 mm | In distribution |
| 100-PRO-04225025-S | Length 50 mm | In distribution |
| 100-PRO-04264530-S | Length 45 mm | In distribution |
| 100-PRO-14225520-S | Height 14 mm | In distribution |
| 100-PRO-04186020-S | Angle 20 ° | In distribution |
| 124-PRO-10102505-S | Height 10 mm | In distribution |
| 100-PRO-12225000-S | Width 22 mm | In distribution |
| 124-PRO-08102505-S | Width 10 mm | In distribution |
| 100-PRO-14186010-S | Length 60 mm | In distribution |
| 124-PRO-11103515-S | Height 11 mm | In distribution |
| 100-PRO-07185000-S | Height 7 mm | In distribution |
| 100-PRO-10226005-S | Height 10 mm | In distribution |
| 120-PRO-07092205-S | Angle 5 ° | In distribution |
| 100-PRO-12185525-S | Length 55 mm | In distribution |
| 100-PRO-04184505-S | Length 45 mm | In distribution |
| 100-PRO-09264015-S | Length 40 mm | In distribution |
| 100-PRO-06266500-S | Height 6 mm | In distribution |
| 100-PRO-10184030-S | Angle 30 ° | In distribution |
| 120-PRO-12092510-S | Depth 25 mm | In distribution |
| 100-PRO-06265005-S | Angle 5 ° | In distribution |
| 100-PRO-10163510-S | Length 35 mm | In distribution |
| 100-PRO-11186020-S | Width 18 mm | In distribution |
| 100-PRO-08224510-S | Length 45 mm | In distribution |
| 100-PRO-10266010-S | Length 60 mm | In distribution |
| 100-PRO-08185515-S | Length 55 mm | In distribution |
| 124-PRO-13103505-S | Height 13 mm | In distribution |
| 100-PRO-08185520-S | Width 18 mm | In distribution |
| 100-PRO-06226015-S | Length 60 mm | In distribution |
| 100-PRO-09264530-S | Width 26 mm | In distribution |
| 100-PRO-10265500-S | Width 26 mm | In distribution |
| 100-PRO-15266500-S | Height 15 mm | In distribution |
| 100-PRO-05266010-S | Angle 10 ° | In distribution |
| 100-PRO-09265510-S | Angle 10 ° | In distribution |
| 100-PRO-06266530-S | Width 26 mm | In distribution |
| 100-PRO-08226005-S | Length 60 mm | In distribution |
| 120-PRO-14092205-S | Angle 5 ° | In distribution |
| 100-PRO-04185520-S | Height 4 mm | In distribution |
| 100-PRO-14266020-S | Height 14 mm | In distribution |
| 100-PRO-14185505-S | Length 55 mm | In distribution |
| 100-PRO-07184520-S | Height 7 mm | In distribution |
| 100-PRO-12186530-S | Length 65 mm | In distribution |
| 120-PRO-11093015-S | Height 11 mm | In distribution |
| 100-PRO-12186000-S | Height 12 mm | In distribution |
| 100-PRO-14185030-S | Length 50 mm | In distribution |
| 100-PRO-10226525-S | Width 22 mm | In distribution |
| 100-PRO-11163500-S | Width 16 mm | In distribution |
| 100-PRO-13186505-S | Length 65 mm | In distribution |
| 120-PRO-09093010-S | Width 9 mm | In distribution |
| 100-PRO-12184005-S | Length 40 mm | In distribution |
| 120-PRO-15092205-S | Angle 5 ° | In distribution |
| 120-PRO-07092210-S | Width 9 mm | In distribution |
| 100-PRO-04184025-S | Height 4 mm | In distribution |
| 100-PRO-06164500-S | Width 16 mm | In distribution |
| 100-PRO-06226510-S | Angle 10 ° | In distribution |
| 100-PRO-04224525-S | Width 22 mm | In distribution |
| 124-PRO-09102505-S | Angle 5 ° | In distribution |
| 100-PRO-07185520-S | Height 7 mm | In distribution |
| 100-PRO-11226025-S | Angle 25 ° | In distribution |
| 100-PRO-05225530-S | Angle 30 ° | In distribution |
| 120-PRO-11092210-S | Angle 10 ° | In distribution |
| 100-PRO-08163010-S | Length 30 mm | In distribution |
| 100-PRO-09226020-S | Length 60 mm | In distribution |
| 100-PRO-04186025-S | Length 60 mm | In distribution |
| 100-PRO-07226510-S | Width 22 mm | In distribution |
| 100-PRO-07185525-S | Length 55 mm | In distribution |
| 100-PRO-08264010-S | Width 26 mm | In distribution |
| 100-PRO-08162500-S | Width 16 mm | In distribution |
| 100-PRO-12264520-S | Angle 20 ° | In distribution |
| 100-PRO-11226020-S | Length 60 mm | In distribution |
| 100-PRO-16224500-S | Height 16 mm | In distribution |
| 100-PRO-11184500-S | Height 11 mm | In distribution |
| 100-PRO-05264030-S | Width 26 mm | In distribution |
| 100-PRO-11186000-S | Width 18 mm | In distribution |
| 124-PRO-13103005-S | Width 10 mm | In distribution |
| 100-PRO-06226020-S | Length 60 mm | In distribution |
| 100-PRO-05225515-S | Angle 15 ° | In distribution |
| 100-PRO-13266020-S | Length 60 mm | In distribution |
| 100-PRO-08226015-S | Length 60 mm | In distribution |
| 100-PRO-05224525-S | Length 45 mm | In distribution |
| 100-PRO-12186525-S | Width 18 mm | In distribution |
| 100-PRO-06185020-S | Width 18 mm | In distribution |
| 100-PRO-11184530-S | Length 45 mm | In distribution |
| 100-PRO-08184010-S | Width 18 mm | In distribution |
| 120-PRO-12093015-S | Depth 30 mm | In distribution |
| 100-PRO-08184510-S | Height 8 mm | In distribution |
| 100-PRO-09264025-S | Length 40 mm | In distribution |
| 100-PRO-12186505-S | Height 12 mm | In distribution |
| 100-PRO-11186505-S | Width 18 mm | In distribution |
| 100-PRO-07184010-S | Angle 10 ° | In distribution |
| 100-PRO-11224530-S | Width 22 mm | In distribution |
| 100-PRO-07266000-S | Height 7 mm | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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.