AVS TL
10 catalogue numbers from 48370164, listed by Stryker GmbH, Switzerland, 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
10catalogue 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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2015-09-14 |
| Record revised | 2020-02-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Angle 0 to 4 °; height 9 to 16 mm; length 25 to 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 48370164 | Angle 4.0 ° | In distribution |
| 48370160 | Height 16.0 mm | In distribution |
| 48370134 | Angle 4.0 ° | In distribution |
| 48370104 | Height 10.0 mm | In distribution |
| 48375114 | Height 11.0 mm | In distribution |
| 48370144 | Angle 4.0 ° | In distribution |
| 48370140 | Angle 0.0 ° | In distribution |
| 48370090 | Height 9.0 mm | In distribution |
| 48370130 | Length 30.0 mm | In distribution |
| 48370124 | Height 12.0 mm | 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 |
|---|---|
| K201585 | 2020-08-10 |
| K143163 | 2015-01-26 |
| K142066 | 2014-11-13 |
| K133328 | 2014-05-30 |
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.