510(k) K103655
- Device
- OCTANE-C INTERBODY FUSION DEVICE SYSTEM
- Applicant
- EXACTECH, INC.
- 510(k) number
- K103655
- Product code
- ODP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-06-30
- Date received
- 2010-12-15
- 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
- PATRICK HUGHES
- Address
- 2320 NW 66th Ct. Gainesville FL US 32653 32653
FDA Registration Numbers#
- 9617297
- 3007604895
- 1226544
- 8010273
- 3007993775
- 3007485169
- 3008864603
- 3006846753
- 3010866843
- 3017065977
- 1000493591
- 3009554293
- 3005819474
- 3006563559
- 3015991317
- 3033739814
- 3043543260
- 3010375065
- 3010646402
- 2531477
- 3036756245
- 3010039400
- 3016460869
- 3011127597
- 1836116
- 1219655
- 3011556898
- 3015941638
- 3005751028
- 3024999441
- 3009756327
- 3016112537
- 3009882462
- 3031787625
- 3023189283
- 3008526708
- 3006217744
- 3016443334
- 3023752918
- 3010120326
- 3004893332
- 2530808
- 2028632
- 3016244279
- 3007279845
- 1043214
- 3010120135
- 3008110533
- 3009169872
- 3010363503
- 3010665091
- 3017565094
- 1047843
- 3031240334
- 1526439
- 3009394448
- 3025602479
- 3008599979
- 3004774118
- 2029275
- 9681465
- 3010041430
- 3009504230
- 1424263
- 3003898943
- 3000170817
- 3036042032
- 3005562917
- 3003935342
- 3008959459
- 3012711663
- 3003678543
- 3018210489
- 2032093
- 3005032068
- 3011683674
- 3017048829
- 3015179588
- 1928237
- 3010509633
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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