Cohere
COHERE ALIF Interbody, 12x34x24mm 25°
3manufacturers in China registered for this device type
103catalogue 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 | Nuvasive, Inc., United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K221751 |
| Record published | 2025-02-03 |
| Record revised | 2025-06-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1962030P2 | In distribution | |
| 1962020P2 | In distribution | |
| 1984420P2 | In distribution | |
| 1984430P2 | In distribution | |
| 1924425P2 | In distribution | |
| 8227855P2 | In distribution | |
| 1964420P2 | In distribution | |
| 1914415P2 | In distribution | |
| 1950200 | In distribution | |
| 1922015P2 | In distribution | |
| 1962010P2 | In distribution | |
| 8187150P2 | In distribution | |
| 1924415P2 | In distribution | |
| 1988825P2 | In distribution | |
| 1988820P2 | In distribution | |
| 1988830P2 | In distribution | |
| 1922025P2 | In distribution | |
| 1950150 | In distribution | |
| 1988815P2 | In distribution | |
| 1908815P2 | In distribution | |
| 1924420P2 | In distribution | |
| 1976215P2 | In distribution | |
| 1962025P2 | In distribution | |
| 1950175 | In distribution | |
| 8180860P2 | In distribution | |
| 1908830P2 | In distribution | |
| 1986215P2 | In distribution | |
| 1924410P2 | In distribution | |
| 8151260P2 | In distribution | |
| 1902015P2 | In distribution | |
| 1986220P2 | In distribution | |
| 1960250 | In distribution | |
| 1922020P2 | In distribution | |
| 1906220P2 | In distribution | |
| 1928815P2 | In distribution | |
| 8187250P2 | In distribution | |
| 1902030P2 | In distribution | |
| 8221060P2 | In distribution | |
| 1902010P2 | In distribution | |
| 1982015P2 | In distribution | |
| 1984410P2 | In distribution | |
| 1968830P2 | In distribution | |
| 1902020P2 | In distribution | |
| 8105515P2 | In distribution | |
| 1950250 | In distribution | |
| 1960175 | In distribution | |
| 8181060P2 | In distribution | |
| 8187245P2 | In distribution | |
| 1914410P2 | In distribution | |
| 1908825P2 | In distribution | |
| 8181245P2 | In distribution | |
| 8260845P2 | In distribution | |
| 1928830P2 | In distribution | |
| 8124515P2 | In distribution | |
| 8187845P2 | In distribution | |
| 8227250P2 | In distribution | |
| 1964430P2 | In distribution | |
| 1950225 | In distribution | |
| 1984415P2 | In distribution | |
| 1982020P2 | In distribution | |
| 8181260P2 | In distribution | |
| 1960225 | In distribution | |
| 1928820P2 | In distribution | |
| 1908820P2 | In distribution | |
| 1908810P2 | In distribution | |
| 8227150P2 | In distribution | |
| 1904425P2 | In distribution | |
| 1922030P2 | In distribution | |
| 1982030P2 | In distribution | |
| 1988810P2 | In distribution | |
| 1982010P2 | In distribution | |
| 1964415P2 | In distribution | |
| 1962015P2 | In distribution | |
| 1928810P2 | In distribution | |
| 1964425P2 | In distribution | |
| 1922010P2 | In distribution | |
| 8181045P2 | In distribution | |
| 8151245P2 | In distribution | |
| 1960150 | In distribution | |
| 1960200 | In distribution | |
| 1906210P2 | In distribution | |
| 1904430P2 | In distribution | |
| 1904420P2 | In distribution | |
| 8150845P2 | In distribution | |
| 1968820P2 | In distribution | |
| 8187255P2 | In distribution | |
| 1976220P2 | In distribution | |
| 1986210P2 | In distribution | |
| 1984425P2 | In distribution | |
| 8260860P2 | In distribution | |
| 1968815P2 | In distribution | |
| 1968810P2 | In distribution | |
| 1982025P2 | In distribution | |
| 1902025P2 | In distribution | |
| 8151045P2 | In distribution | |
| 1968825P2 | In distribution | |
| 1928825P2 | In distribution | |
| 1976210P2 | In distribution | |
| 8261045P2 | In distribution | |
| 1924430P2 | In distribution | |
| 1906215P2 | In distribution | |
| 8267150P2 | In distribution | |
| 1964410P2 | 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 |
|---|---|
| K131723 | 2013-09-20 |
| K123045 | 2013-04-16 |
| K112561 | 2012-03-13 |
| K100043 | 2010-06-16 |
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.