Solitaire® Anterior Spinal System
45 catalogue numbers from 14-530063, listed by Biomet Spine, United States, under Intervertebral Fusion Device With Integrated Fixation, Lumbar. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
45catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Record published | 2021-04-07 |
| Record revised | 2025-01-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-530063 | Solitaire® PEEK 16 mm 0° Wide | In distribution |
| 14-530054 | Solitaire® PEEK 18 mm 12° Medium | In distribution |
| 14-530085 | Solitaire® PEEK 20 mm 12° Wide | In distribution |
| 14-530012 | Solitaire® PEEK 14 mm 6° Narrow | In distribution |
| 14-530015 | Solitaire® PEEK 20 mm 6° Narrow | In distribution |
| 14-530064 | Solitaire® PEEK 18 mm 0° Wide | In distribution |
| 14-530061 | Solitaire® PEEK 12 mm 0° Wide | In distribution |
| 14-530065 | Solitaire® PEEK 20 mm 0° Wide | In distribution |
| 14-530053 | Solitaire® PEEK 16 mm 12° Medium | In distribution |
| 14-530001 | Solitaire® PEEK 12 mm 0° Narrow | In distribution |
| 14-530044 | Solitaire® PEEK 18 mm 6° Medium | In distribution |
| 14-530022 | Solitaire® PEEK 14 mm 12° Narrow | In distribution |
| 14-530055 | Solitaire® PEEK 20 mm 12° Medium | In distribution |
| 14-530031 | Solitaire® PEEK 12 mm 0° Medium | In distribution |
| 14-530081 | Solitaire® PEEK 12 mm 12° Wide | In distribution |
| 14-530002 | Solitaire® PEEK 14 mm 0° Narrow | In distribution |
| 14-530032 | Solitaire® PEEK 14 mm 0° Medium | In distribution |
| 14-530003 | Solitaire® PEEK 16 mm 0° Narrow | In distribution |
| 14-530042 | Solitaire® PEEK 14 mm 6° Medium | In distribution |
| 14-530013 | Solitaire® PEEK 16 mm 6° Narrow | In distribution |
| 14-530082 | Solitaire® PEEK 14 mm 12° Wide | In distribution |
| 14-530084 | Solitaire® PEEK 18 mm 12° Wide | In distribution |
| 14-530075 | Solitaire® PEEK 20 mm 6° Wide | In distribution |
| 14-530073 | Solitaire® PEEK 16 mm 6° Wide | In distribution |
| 14-530074 | Solitaire® PEEK 18 mm 6° Wide | In distribution |
| 14-530023 | Solitaire® PEEK 16 mm 12° Narrow | In distribution |
| 14-530024 | Solitaire® PEEK 18 mm 12° Narrow | In distribution |
| 14-530051 | Solitaire® PEEK 12 mm 12° Medium | In distribution |
| 14-530033 | Solitaire® PEEK 16 mm 0° Medium | In distribution |
| 14-530062 | Solitaire® PEEK 14 mm 0° Wide | In distribution |
| 14-530083 | Solitaire® PEEK 16 mm 12° Wide | In distribution |
| 14-530071 | Solitaire® PEEK 12 mm 6° Wide | In distribution |
| 14-530035 | Solitaire® PEEK 20 mm 0° Medium | In distribution |
| 14-530011 | Solitaire® PEEK 12 mm 6° Narrow | In distribution |
| 14-530072 | Solitaire® PEEK 14 mm 6° Wide | In distribution |
| 14-530004 | Solitaire® PEEK 18 mm 0° Narrow | In distribution |
| 14-530043 | Solitaire® PEEK 16 mm 6° Medium | In distribution |
| 14-530052 | Solitaire® PEEK 14 mm 12° Medium | In distribution |
| 14-530041 | Solitaire® PEEK 12 mm 6° Medium | In distribution |
| 14-530005 | Solitaire® PEEK 20 mm 0° Narrow | In distribution |
| 14-530034 | Solitaire® PEEK 18 mm 0° Medium | In distribution |
| 14-530021 | Solitaire® PEEK 12 mm 12° Narrow | In distribution |
| 14-530045 | Solitaire® PEEK 20 mm 6° Medium | In distribution |
| 14-530025 | Solitaire® PEEK 20 mm 12° Narrow | In distribution |
| 14-530014 | Solitaire® PEEK 18 mm 6° Narrow | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141791 | 2014-10-09 |
| K093629 | 2010-03-09 |
| K081501 | 2008-07-02 |
| K081395 | 2008-06-25 |
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.