510(k) K243191
- Device
- Atlas Spine Lateral Expandable Interbody System
- Applicant
- Atlas Spine, Inc.
- 510(k) number
- K243191
- Product code
- OVD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-11-26
- Date received
- 2024-09-30
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Thomas Smith
- Address
- 1555 Jupiter Park Dr. Suite 1 Jupiter FL US 33458 33458
FDA Registration Numbers#
- 1935627
- 3007303113
- 2532027
- 3010047454
- 3006639944
- 3007728266
- 1000200989
- 3016460869
- 3010160527
- 1226544
- 3017528621
- 3004188066
- 3003935342
- 3010047402
- 1420032
- 3008812560
- 3017565094
- 1220477
- 1828464
- 3016237080
- 1924669
- 3019767615
- 2031966
- 3006404071
- 3005031160
- 3003637761
- 3018210489
- 3015216945
- 1030489
- 3007993775
- 2135156
- 3012428435
- 3009882462
- 3013422236
- 3013820501
- 3005497913
- 3010386387
- 1527105
- 3008992889
- 3004112448
- 3003639920
- 9616680
- 2531477
- 3010120148
- 3004024955
- 3005739886
- 3013194153
- 3015151147
- 3039167712
- 3026776
- 3003435550
- 3005180920
- 9610612
- 2183946
- 3009241418
- 3009051471
- 3005706667
- 3010197224
- 3013055499
- 3005144609
- 3006563559
- 3024999441
- 3016438694
- 3009504230
- 3015212339
- 3010041430
- 1424434
- 3016050940
- 3015882686
- 3015941638
- 3012764194
- 1529009
- 3007766698
- 3004499989
- 3011795235
- 2031093
- 3009380063
- 3012028003
- 3014655115
- 3005819474
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OVD#
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|---|---|---|---|
| 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 |