510(k) K082406
- Device
- EXPANDABLE PEEK-OPTIMA IMPLANT
- Applicant
- EBI, L.P.
- 510(k) number
- K082406
- Product code
- MAX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-01-14
- Date received
- 2008-08-21
- Regulation
- 888.3080
- Classification name
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- VIVIAN KELLY
- Address
- 399 Jefferson Rd. Parsippany NJ US 07054 07054
FDA Registration Numbers#
- 3005042595
- 3017780544
- 2245304
- 3009923578
- 3011390763
- 3014725904
- 3011127597
- 3005562917
- 3009973699
- 3021006165
- 3010041430
- 1000200989
- 3005083075
- 3012863589
- 3009959868
- 3014315669
- 3006783837
- 3007887127
- 3016237080
- 3007200272
- 3015426608
- 3020307303
- 3004142400
- 3000170817
- 1724955
- 1221763
- 3014937101
- 3015398319
- 3010175289
- 3022159082
- 1528646
- 3016002322
- 3013111980
- 3004788213
- 2531477
- 3004153896
- 9680515
- 1526439
- 3011187779
- 3014346934
- 3017980495
- 3013491327
- 3010032903
- 2027467
- 1720929
- 3005739886
- 3011181154
- 3008534770
- 3015487912
- 3013014058
- 3037407500
- 3008864603
- 1828464
- 1833506
- 3010326971
- 3004774118
- 3010531060
- 3012428435
- 3007125392
- 9617544
- 2028632
- 9681465
- 1835444
- 3010863450
- 3036042032
- 2530808
- 3012966183
- 3005977257
- 1000432246
- 3015941638
- 3010143171
- 3009404219
- 3013548554
- 3007766601
- 8010273
- 3015869493
- 3016099068
- 3006404071
- 9615766
- 3007539489
Source Documents#
Other 510(k) Records For Product Code MAX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261159 | Exceed® Biplanar Expandable Interbody System | Spine Wave, Inc. | 2026-05-29 |
| K253894 | BMD Titanium Spinal Fusion System | Global Biomedica s.r.o. | 2026-05-28 |
| K260506 | Ventana® P/T Lumbar Interbody System | Spinal Elements, Inc. | 2026-05-15 |
| K260837 | VersaLift Expandable System | Life Spine, Inc. | 2026-05-12 |
| K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system | Carlsmed, Inc. | 2026-05-09 |
| K261067 | BEE PLIF Cage | NGMedical GmbH | 2026-04-30 |
| K254017 | SWINGO-3D Lumbar Cage System | Implanet | 2026-02-26 |
| K253583 | LUX Expandable Lumbar Interbody System | Xenix Medical | 2026-02-23 |
| K250773 | Luna® Ti Interbody Fusion System | Spinal Elements, Inc. | 2026-02-04 |
| K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System | Life Spine, Inc. | 2026-01-23 |
| K253266 | Titanium Interbody System | Spine Innovation, LLC | 2026-01-08 |
| K253577 | IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) | Medicrea International S.A.S. (Medtronic) | 2025-12-19 |
| K252610 | ZSFab Lumbar Interbody System | Zsfab, Inc. | 2025-11-25 |
| K252351 | UniSpace® TPLIF Cage | Cg Medtech Co., Ltd. | 2025-10-28 |
| K253377 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, Inc. | 2025-10-24 |
Legacy Summary#
summary
FDA Review#
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