510(k) K072289
- Device
- SPINEFRONTIER DORADO VBR
- Applicant
- SPINEFRONTIER, INC.
- 510(k) number
- K072289
- Product code
- MAX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-11-01
- Date received
- 2007-08-16
- 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
- TOM CARLSON
- Address
- 100 Cummings Center Suite 240c Beverly MA US 01915 01915
FDA Registration Numbers#
- 9617297
- 3007604895
- 1226544
- 8010273
- 3007993775
- 3007485169
- 3008864603
- 3006846753
- 3016099068
- 3010866843
- 3017065977
- 1000493591
- 3009554293
- 3005819474
- 9615766
- 3006563559
- 3033739814
- 3017780544
- 3043543260
- 3010375065
- 3010370880
- 3010646402
- 2531477
- 3013514648
- 3036756245
- 3013546462
- 3010039400
- 3016460869
- 3011127597
- 1828288
- 1219655
- 3011556898
- 3015941638
- 3005751028
- 3024999441
- 3009756327
- 3016112537
- 3009882462
- 2133687
- 3008526708
- 3006217744
- 3016443334
- 3023752918
- 3010120326
- 3004893332
- 2531195
- 2530808
- 2028632
- 3016244279
- 3007279845
- 3010120135
- 3008110533
- 3009169872
- 3010363503
- 3007289746
- 3010665091
- 3017565094
- 1047843
- 3031240334
- 3014252644
- 1526439
- 1527105
- 1221763
- 3025602479
- 3008599979
- 3008102042
- 3004774118
- 2029275
- 9681465
- 3010041430
- 3009504230
- 1424263
- 3003898943
- 9680515
- 3012028003
- 3000170817
- 3015255331
- 3036042032
- 3005562917
- 3016261131
Source Documents#
Other 510(k) Records For Product Code MAX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262646 | Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System | Alphatec Spine, Inc. | 2026-10-21 |
| K261049 | SCALA® TL | Spineart SA | 2026-08-20 |
| K261430 | TruLift Expandable System | Life Spine, Inc. | 2026-07-28 |
| K253011 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2026-07-17 |
| K261020 | Symmetrix™ L Spinal System | Medtronic Sofamor Danek USA, Inc. | 2026-07-14 |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy | SeaSpine Orthopedics Corporation | 2026-07-01 |
| K253151 | Fule Interbody Fusion Cage System | Beijing Fule Science & Technology Development Co., Ltd. | 2026-06-15 |
| 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 |
Legacy Summary#
summary
FDA Review#
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