510(k) K203520
- Device
- Blustone Synergy Interbody Fusion System
- Applicant
- Blustone Synergy, LLC
- 510(k) number
- K203520
- Product code
- ODP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-04-07
- Date received
- 2020-12-01
- 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
- Tom Gentry
- Address
- 5520 Ventana Ct. Pueblo CO US 81005 81005
FDA Registration Numbers#
- 3013462427
- 3017597868
- 3013921069
- 3009165919
- 3010763958
- 3010663372
- 1424434
- 3013548554
- 3025603301
- 1528646
- 3022295665
- 3009217531
- 3006493760
- 3016443334
- 3005497913
- 3014725904
- 3007441485
- 3036042032
- 3014655115
- 2032521
- 3006128100
- 3009538923
- 3006217744
- 3007210720
- 3009394448
- 3009998573
- 3019356409
- 3011513267
- 1720929
- 3007887127
- 9616680
- 3010173425
- 3007728266
- 3016112537
- 1835251
- 3005325790
- 1724955
- 3000270450
- 9615128
- 3013413393
- 3010041499
- 3010646402
- 3010178296
- 3010863450
- 3009049161
- 3003898943
- 1450662
- 1530390
- 3010047454
- 2647346
- 3009106092
- 8043792
- 3003935342
- 3008868758
- 3010049501
- 3011390763
- 3010197239
- 1935627
- 3009504230
- 1319660
- 3009888740
- 3018210489
- 3010370500
- 3010509633
- 3013422236
- 3016438694
- 3022943642
- 3009756327
- 3006639944
- 3008285983
- 2029275
- 1834331
- 3004188066
- 3015426608
- 3002807112
- 3027726367
- 3007922509
- 3009732568
- 3004719693
- 3015831087
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#
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FDA Review#
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