510(k) K131216
- Device
- RAMPART O
- Applicant
- SPINEOLOGY, INC.
- 510(k) number
- K131216
- Product code
- MAX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-05-30
- Date received
- 2013-04-30
- Regulation
- 888.3080
- Classification name
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRYAN BECKER
- Address
- 7800 3rd St. N. Suite 600 Saint Paul MN US 55128 55128
FDA Registration Numbers#
- 3004142400
- 3016050940
- 1422634
- 9617544
- 3005677016
- 3011127597
- 3008868758
- 3015216945
- 3010509633
- 3019356409
- 1221763
- 9611813
- 1423662
- 3010009693
- 3014252644
- 3009882675
- 3007303113
- 3009106092
- 3003526896
- 3005144609
- 3009381600
- 3009504230
- 3016002322
- 1000517406
- 3013055499
- 3014315669
- 2133687
- 8010944
- 3007728266
- 3011390763
- 2032093
- 1056553
- 3012764194
- 3010370554
- 3005032068
- 3013111980
- 3014967969
- 3005042595
- 3005596514
- 3021559833
- 3009826895
- 3031240334
- 3006563559
- 1223434
- 3009973699
- 3004049923
- 3016099068
- 2183744
- 3010363503
- 3015941638
- 3017435639
- 3014019090
- 3009404219
- 3005083075
- 3015151147
- 3007200272
- 2031966
- 1424434
- 1528646
- 1649379
- 3014655115
- 3008773560
- 3021945817
- 1000493591
- 1834331
- 3003761012
- 3017521423
- 3007539489
- 3014257776
- 3003955307
- 2531195
- 3010287685
- 1835572
- 3014725904
- 3006487372
- 3012994232
- 1529009
- 3009973505
- 9681465
Source Documents#
Other 510(k) Records For Product Code MAX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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