510(k) K150812
- Device
- Genesys Spine Apache Cervical Interbody Fusion System
- Applicant
- Genesys Spine
- 510(k) number
- K150812
- Product code
- ODP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-09-03
- Date received
- 2015-03-26
- Regulation
- 888.3080
- Classification name
- Intervertebral Fusion Device With Bone Graft, Cervical
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Dave Lamb
- Address
- 1250 Capital Of Texas Hwy. Bldg. Three Suite 600 Austin TX US 78746 78746
FDA Registration Numbers#
- 1833920
- 3015941638
- 1000517406
- 3015991317
- 3015179588
- 3003855635
- 1047843
- 3008864603
- 1226544
- 3021945817
- 3010646402
- 3009417901
- 3009217531
- 3021180147
- 3017435639
- 3014967552
- 9681465
- 3016237080
- 3019837678
- 3010162973
- 3008285983
- 3011127597
- 3009189869
- 1835251
- 3008526708
- 3010560653
- 1060840
- 3004176895
- 3006791286
- 3009882675
- 3010120326
- 3012711663
- 8020776
- 3015398319
- 3033739814
- 3037407500
- 3004499989
- 3007334927
- 1824199
- 3015709929
- 3025603301
- 3007485169
- 3009957608
- 3012764194
- 9611390
- 1834331
- 3007922509
- 3004638532
- 3005497913
- 1828464
- 3019878714
- 3006017180
- 3009882462
- 1219655
- 1928237
- 3009998573
- 3018094310
- 2031966
- 9617297
- 3010705004
- 3004142400
- 3041915189
- 1720929
- 3014937101
- 3015216945
- 3010041430
- 3009241418
- 3010032903
- 3010009693
- 3011577940
- 1833824
- 3004774118
- 2647346
- 3023752918
- 3013548554
- 3007728266
- 3016438694
- 3010097171
- 3030183061
Source Documents#
Other 510(k) Records For Product Code ODP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253041 | 3d Cage Cervical | Fims Co., Ltd. | 2026-07-23 |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM | Stryker Spine | 2026-07-17 |
| K254130 | C.A. Medical Interbody Fusion System | C.A. Medical, LLC | 2026-07-08 |
| K260840 | BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | 2026-05-16 |
| K260850 | OSTEOMNI SPINAL CAGES SYSTEM | Osteomni, Inc. | 2026-05-12 |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System | Zsfab, Inc. | 2026-04-24 |
| K253260 | ORIO-3D Cage System | SpineCraft | 2026-04-16 |
| K260340 | HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES | HC Biologics, LLC | 2026-04-13 |
| K242303 | MOD-C | Orthomod, LLC | 2026-04-01 |
| K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine | 2026-03-30 |
| K252432 | Flex-Z™ Cervical Cage | Spinepoint, LLC | 2026-03-25 |
| K254105 | Hive™ Standalone Cervical System and Hive™ C Interbody System | NanoHive Medical, LLC | 2026-02-13 |
| K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | 2026-01-16 |
| K254061 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | 2026-01-15 |
| K252219 | Cervical Interbody and VBR Fusion System | Sync Surgical | 2026-01-14 |
Legacy Summary#
summary
FDA Review#
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