Atec Porous Ti Interbody System
PO Trial, 12P x 14A x 10W x 25L , 10°
1manufacturer
24catalogue 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 | 2020-03-02 |
| Record revised | 2024-09-11 (version 2) |
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 | Angle 5 to 15 °; length 25 to 30 mm; height 7 to 12 mm; width 9 to 12 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 94137-019 | Angle 10 ° | In distribution |
| 94242 | In distribution | |
| 94132-0238 | Length 25 mm | In distribution |
| 94137-169 | Height 8 mm | In distribution |
| 94137-113 | Angle 5 ° | In distribution |
| 94231 | In distribution | |
| 94237-200 | In distribution | |
| 94132-0240 | Length 25 mm | In distribution |
| 94133-086 | Length 30 mm | In distribution |
| 94137-129 | Width 10 mm | In distribution |
| 94137-001 | Width 10 mm | In distribution |
| 94132-0243 | Angle 10 ° | In distribution |
| 94137-171 | Width 12 mm | In distribution |
| 94133-087 | Angle 5 ° | In distribution |
| 94232 | In distribution | |
| 94132-0253 | Width 9 mm | In distribution |
| 94133-089 | Angle 5 ° | In distribution |
| 94133-115 | Width 10 mm | In distribution |
| 94137-003 | Width 10 mm | In distribution |
| 94133-099 | Height 7 mm | In distribution |
| 94237-100-02 | In distribution | |
| 94133-102 | Angle 10 ° | In distribution |
| 94132-0241 | Length 25 mm | In distribution |
| 94237-120-02 | 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.