Independence MIS
Independence MIS is an anterior lumbar interbody spacer used to support the disc space after discectomy. Screws or anchors pass through the implant's anterior titanium portion into the…
Independence MIS is an anterior lumbar interbody spacer used to support the disc space after discectomy. Screws or anchors pass through the implant’s anterior titanium portion into the adjacent vertebral bodies.
The family includes titanium alloy implants and titanium-polymer configurations with radiographic markers. Upper and lower surface protrusions engage the vertebral endplates. PEEK versions can have a titanium plasma-sprayed coating, while screws and anchors have optional hydroxyapatite coatings.
Listed Item
INDEPENDENCE MIS SPACER, 29 x 39mm 15°, 13mm
Fixation Configurations
Three titanium alloy screws permit standalone use in the specified applications. Anchor configurations require supplemental fixation, as do hyperlordotic implants with lordosis of 25 degrees or more. The spacer is filled with autograft or allogenic bone graft and is intended for one- or two-level fusion from L2 to S1.
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 | Globus Medical, 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 | Manufacturer, Exporter |
| 510(k) | K160597 |
| Record published | 2025-07-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3135.1213 | In distribution | |
| 3135.0813 | In distribution | |
| 3135.0121 | In distribution | |
| 3135.0211 | In distribution | |
| 3135.0215 | In distribution | |
| 3135.1113 | In distribution | |
| 3135.0821 | In distribution | |
| 3135.0317 | In distribution | |
| 3135.1217 | In distribution | |
| 3135.1219 | In distribution | |
| 3135.0613 | In distribution | |
| 3135.0817 | In distribution | |
| 3135.0213 | In distribution | |
| 3135.0819 | In distribution | |
| 3135.0721 | In distribution | |
| 3135.1121 | In distribution | |
| 3135.0117 | In distribution | |
| 3135.1119 | In distribution | |
| 3135.0717 | In distribution | |
| 3135.0321 | In distribution | |
| 3135.0221 | 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 |
|---|---|
| K253401 | 2026-04-29 |
| K201087 | 2020-07-31 |
| K170157 | 2017-09-25 |
| K161379 | 2016-09-29 |
| K160597 | 2016-08-29 |
| K161223 | 2016-07-15 |
| K142498 | 2015-02-26 |
| K132559 | 2013-12-30 |
| K120101 | 2012-03-27 |
| K103382 | 2011-05-20 |
| K082252 | 2008-11-05 |
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.