510(k) K083167
- Device
- PHENIX CERVICAL INTERBODY DEVICE
- Applicant
- SPINAL DEVICES, LLC
- 510(k) number
- K083167
- Product code
- ODP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-01-13
- Date received
- 2008-10-27
- 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
- RICHARD JANSEN
- Address
- 13540 Guild Ave. Apple Valley MN US 55124 55124
FDA Registration Numbers#
- 3003935342
- 3012131184
- 3007604895
- 3036496433
- 1722511
- 3010160527
- 3022943642
- 3009882675
- 3009538923
- 3008455034
- 3010763958
- 3011683674
- 3018044926
- 1221051
- 8020776
- 3011127597
- 3006017180
- 3030412764
- 3030183061
- 3003597504
- 3011577940
- 3007993775
- 3015941638
- 3007675554
- 3006378738
- 3013820501
- 3015151147
- 3010123206
- 3010370500
- 3005596514
- 3008992889
- 3013422238
- 3003639920
- 3004719693
- 3013055499
- 2183449
- 3010866843
- 3007441485
- 3010041430
- 3015831087
- 3013548554
- 3006563559
- 2134470
- 3009165919
- 1720929
- 1526534
- 3016460869
- 1000493591
- 9611813
- 3007887127
- 3019837678
- 9617297
- 3005032068
- 1047843
- 1834331
- 3009888740
- 3010531060
- 3014273501
- 3014725904
- 3008110533
- 3011796723
- 3009106092
- 3004638532
- 3008812560
- 3008850074
- 3010173425
- 1935627
- 3004499989
- 3027726367
- 3008285983
- 3009959868
- 3016438694
- 3010375065
- 3033509898
- 3009394448
- 3007344102
- 3009381600
- 3005751028
- 3004635447
- 3031787625
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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