General Instruments
C-C Angled ALIF TRIAL, 11 x 38 x 28 mm, 10°
1manufacturer
11catalogue 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 | 2021-08-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Height 5 to 11 mm; width 34 to 38 mm; angle 10 to 20 °; length 24 to 28 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CI-10479-114- 07382810 | Height 7 mm | In distribution |
| CI-10479-114- 06342420 | Length 24 mm | In distribution |
| CI-10479-114-05382810 | Angle 10 ° | In distribution |
| CI-10479-114- 08342415 | Length 24 mm | In distribution |
| CI-10479-130-11382810 | Length 28 mm | In distribution |
| CI-10479-114- 08342410 | Height 8 mm | In distribution |
| CI-10479-114-10342410 | Width 34 mm | In distribution |
| CI-10479-114- 09382815 | Height 9 mm | In distribution |
| CI-10479-114-11382810 | Height 11 mm | In distribution |
| CI-10479-114- 06382820 | Width 38 mm | In distribution |
| CI-10479-114- 06342415 | Length 24 mm | 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 |
| IdentiTi II | Alphatec Spine, Inc. | 163 |
| Modulus | Nuvasive, Inc. | 158 |
| Hedron | Globus Medical, Inc. | 156 |
| Roccia | Silony Medical Gmbh | 133 |
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.