510(k) K180002
- Device
- Rampart One Lumbar Interbody Fusion Device
- Applicant
- Spineology Inc.
- 510(k) number
- K180002
- Product code
- OVD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-04-25
- Date received
- 2018-01-02
- Regulation
- 888.3080
- Classification name
- Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jacqueline A. Hauge
- Address
- 7800 3rd St. N. Suite 600 Saint Paul MN US 55128 55128
FDA Registration Numbers#
- 3013462427
- 3005706667
- 3017597868
- 2648623
- 3010462278
- 3012028003
- 3011127597
- 1526439
- 1649518
- 3008773560
- 3005819474
- 3026776
- 3009380063
- 3005178931
- 3010032903
- 3010663372
- 3013491327
- 1424434
- 3003120897
- 3013422238
- 8020776
- 1226544
- 3004717358
- 3005739886
- 3009957608
- 3012764194
- 9611813
- 3004635447
- 3033509898
- 3008992889
- 3025603301
- 3005596514
- 3003435550
- 3007344102
- 3022295665
- 3006846753
- 3016443334
- 3005497913
- 3009959868
- 3014725904
- 2134285
- 3010120326
- 3005061536
- 3014655115
- 1526534
- 3008850074
- 1833920
- 3017528621
- 3010097171
- 2183744
- 2028632
- 3006128100
- 9611390
- 1928237
- 3002807561
- 2031093
- 3006694268
- 3009882462
- 3015869492
- 1649379
- 3016050940
- 3006982954
- 3015151147
- 3010120135
- 3005031160
- 3006017180
- 1833986
- 3015941638
- 3009973505
- 3010120104
- 3004893332
- 3004112448
- 3012491394
- 3010160527
- 3018094310
- 2135156
- 3010866843
- 3009998573
- 3006791286
- 3009973336
Source Documents#
Other 510(k) Records For Product Code OVD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System | INNO Holdings Inc. DBA Innovasis | 2026-09-11 |
| K261408 | SABER-XA System | Elevation Spine | 2026-08-03 |
| K261809 | Interwedge® Standalone Lateral | Foundation Surgical Group | 2026-07-31 |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System | Kyocera Medical Technologies, Inc. | 2026-07-15 |
| K260810 | Anteralign LS coverplate | Tyber Medical, LLC | 2026-06-10 |
| K254202 | MectaLIF 3D Metal Anterior | Medacta International S.A. | 2026-05-05 |
| K253401 | SCRIPT™ Implant System | Globus Medical, Inc. | 2026-04-29 |
| K253559 | Ventana™ A Anterior Lumbar Interbody System | Spinal Elements, Inc. | 2026-02-25 |
| K251829 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | 2025-12-08 |
| K251575 | IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System | Alphatec Spine | 2025-09-03 |
| K250072 | CONDUIT™ SYNFIX™ Evolution Secured Spacer System | Avalign Technologies, Inc. | 2025-07-10 |
| K251644 | ProAM ALIF System | Pro Surgical, Inc. | 2025-06-24 |
| K250845 | Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | 2025-06-18 |
| K251459 | OneLIF™ Interbody Fusion System | Novapproach Spine, LLC | 2025-06-12 |
| K243934 | Stable-L Lumbar Interbody System | Nexus Spine, LLC | 2025-04-30 |
Legacy Summary#
summary
FDA Review#
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