SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE
FDA 510(k) clearance K122518 · decided 2013-02-15
Clearance details
- K-number
- K122518
- Device name
- SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE
- Applicant
- Bm Korea Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2012-08-17
- Decision date
- 2013-02-15
- Days to decision
- 182 days
- Clearance type
- Special
- Product code
- ODP
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Fullerton, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| 3d Cage Cervical (K253041) | Fims Co., Ltd. | 2026-07-23 |
| 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 (K262061) | Stryker Spine | 2026-07-17 |
| C.A. Medical Interbody Fusion System (K254130) | C.A. Medical, LLC | 2026-07-08 |
| BluEX Cervical Expandable Cage System (K260840) | L&K BIOMED Co., Ltd. | 2026-05-16 |
| OSTEOMNI SPINAL CAGES SYSTEM (K260850) | Osteomni, Inc. | 2026-05-12 |
| ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (K260549) | Zsfab, Inc. | 2026-04-24 |
| ORIO-3D Cage System (K253260) | SpineCraft | 2026-04-16 |
| HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES (K260340) | HC Biologics, LLC | 2026-04-13 |
| MOD-C (K242303) | Orthomod, LLC | 2026-04-01 |
| Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (K252240) | Spectrum Spine | 2026-03-30 |
| Flex-Z™ Cervical Cage (K252432) | Spinepoint, LLC | 2026-03-25 |
| Hive™ Standalone Cervical System and Hive™ C Interbody System (K254105) | NanoHive Medical, LLC | 2026-02-13 |
Recalls involving this device
No recalls on record reference this clearance.