510(k) K180502
- Device
- S128 Anterior Lumbar Interbody Fusion (ALIF) System
- Applicant
- Renovis Surgical Technologies Inc.
- 510(k) number
- K180502
- Product code
- OVD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-06-14
- Date received
- 2018-02-26
- 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
- Anthony DeBenedictis
- Address
- 1901 W. Lugonia Ave., Suite 340 Redlands CA US 92374 92374
FDA Registration Numbers#
- 1835251
- 3009380063
- 3011127597
- 1526711
- 3007922509
- 3010097171
- 1834331
- 3012120772
- 3010047454
- 3010326971
- 3014252644
- 9617544
- 2029275
- 1000432246
- 3010462278
- 1225492
- 3006982954
- 3010057495
- 3012447612
- 2648623
- 3005061536
- 3010386387
- 3012428435
- 3004635447
- 3009149199
- 3004774118
- 1030489
- 3009241418
- 3004638600
- 3037407500
- 9616680
- 3010120326
- 1833920
- 3017048829
- 3007344102
- 3008110533
- 3010705004
- 3003639920
- 3009144915
- 3010663372
- 1319660
- 3008773560
- 1450662
- 3006128100
- 2531195
- 3017980495
- 3013758617
- 3016460869
- 1526439
- 3010370500
- 1833986
- 2032098
- 3004153896
- 3003935342
- 3007289746
- 3009998573
- 2031966
- 3013491327
- 2133928
- 3016438694
- 2135156
- 3003387384
- 3009887475
- 3013462427
- 3010866843
- 1935627
- 3006783837
- 3010197239
- 3010560653
- 1000517406
- 3012711663
- 3015216945
- 8020776
- 9681465
- 3005819474
- 1828464
- 3015941638
- 3008850074
- 3000270450
- 3043543260
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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