510(k) K083425
- Device
- FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE
- Applicant
- ADAPTIVE SPECIALTY, LLC
- 510(k) number
- K083425
- Product code
- ODP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-03-20
- Date received
- 2008-11-19
- Regulation
- 888.3080
- Classification name
- Intervertebral Fusion Device With Bone Graft, Cervical
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- J.D. WEBB
- Address
- 1001 Oakwood Blvd. Round Rock TX US 78681 78681
FDA Registration Numbers#
- 2183449
- 2183946
- 3012120772
- 1834379
- 1833506
- 3016244279
- 3006110997
- 1526534
- 1030489
- 3004464325
- 3008868758
- 3010531060
- 3010120104
- 3016050940
- 3013422238
- 1220477
- 3010039400
- 3015941638
- 3008285983
- 3012447612
- 3009538923
- 3010665091
- 3007334927
- 3008992889
- 3011556898
- 3005977257
- 3010197224
- 3010287685
- 1450662
- 3006404071
- 3019837678
- 3017980495
- 3016237080
- 3009144915
- 3011301313
- 3003639920
- 9610612
- 3009129735
- 1649379
- 3019767615
- 3009394448
- 3010047454
- 2031966
- 3004635447
- 3009189869
- 3009381600
- 1833824
- 2027062
- 3005144609
- 3010120326
- 3004788213
- 3010041499
- 3008583793
- 1824199
- 3014019090
- 1424263
- 1928237
- 3013548554
- 3010123206
- 1834331
- 1720929
- 1054811
- 3015207155
- 3021588295
- 2134285
- 3010763958
- 3031081659
- 3008599979
- 3023434937
- 9617297
- 3017565094
- 3017435639
- 3009165919
- 1221051
- 2028632
- 3003898943
- 3015179588
- 3048284429
- 3011181154
Source Documents#
Other 510(k) Records For Product Code ODP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262595 | VariLift-C Cervical Interbody Fusion System | Wenzel Spine, Inc. | 2026-08-26 |
| K262489 | BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | 2026-08-18 |
| 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 |
Legacy Summary#
summary
FDA Review#
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