510(k) K173606
- Device
- SeaSpine Vu A•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu A•POD Prime Intervertebral Body Fusion Device
- Applicant
- SeaSpine Orthopedics Corporation
- 510(k) number
- K173606
- Product code
- OVD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-04-13
- Date received
- 2017-11-21
- 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
- Gina Flores
- Address
- 5770 Armada Dr. Carlsbad CA US 92008 92008
FDA Registration Numbers#
- 3005677016
- 3005706667
- 3008583793
- 2032093
- 3031081659
- 3004638600
- 1526711
- 3010123206
- 3011390763
- 3014725904
- 1834379
- 3012120772
- 3016438694
- 3003761012
- 3011127597
- 3030412764
- 3009051471
- 1924669
- 3005144609
- 3003477135
- 3009973699
- 2183449
- 3015212339
- 3010041430
- 3016668776
- 3007922509
- 3010162973
- 1000200989
- 3008868758
- 3009888740
- 3010705004
- 3006846753
- 3005031160
- 1226544
- 3009959868
- 3013413393
- 3014967969
- 3008850074
- 3010120104
- 3003637761
- 3013758617
- 3005641619
- 1530390
- 1000517406
- 3006783837
- 3009973336
- 3007993775
- 3010049501
- 3010160527
- 3013820501
- 1527105
- 1030489
- 3006791286
- 2031966
- 2183744
- 3016237080
- 3010057495
- 3013194153
- 3007766698
- 3004893332
- 3015216945
- 3005178931
- 1529009
- 2532027
- 8043792
- 3005819474
- 3020307303
- 3004142400
- 1424434
- 3008773560
- 3014680795
- 3017936978
- 2032521
- 3013462427
- 3000170817
- 1724955
- 1450662
- 3006128100
- 1221763
- 3015398319
Source Documents#
Other 510(k) Records For Product Code OVD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K243386 | Ventris Intervertebral Body Fusion Device | Acuity Surgical Devices, LLC | 2025-04-22 |
| K250603 | AxTiHA® Stand-Alone ALIF System | Innovasis | 2025-03-24 |
| K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2025-03-17 |
| K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2024-12-13 |
| K243191 | Atlas Spine Lateral Expandable Interbody System | Atlas Spine, Inc. | 2024-11-26 |
Legacy Summary#
summary
FDA Review#
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