510(k) K232822
- Device
- Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)
- Applicant
- Gbs Commonwealth Co., Ltd.
- 510(k) number
- K232822
- Product code
- ODP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-10-13
- Date received
- 2023-09-13
- Regulation
- 888.3080
- Classification name
- Intervertebral Fusion Device With Bone Graft, Cervical
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jimmy Kim
- Address
- C-309. Woolim Lion'S Valley, 168, Gasan Digital 1-Ro Geumcheon-Gu KR 08507 08507
FDA Registration Numbers#
- 3010123206
- 3003525643
- 1824199
- 9615128
- 3013055499
- 3010370500
- 3017936978
- 3006563559
- 3008114965
- 8010273
- 3021945817
- 3006082533
- 1000432246
- 3006487372
- 3009129735
- 3005751028
- 3023138345
- 1225492
- 3010120104
- 2953359
- 1000461041
- 3011181154
- 1529009
- 8043792
- 3014680795
- 3005061536
- 1834331
- 3014967552
- 3042175940
- 3005677016
- 3010326971
- 3009756327
- 3009973505
- 2530808
- 3025602479
- 3015991317
- 3013462427
- 3016050940
- 1047843
- 3006128100
- 3007993775
- 3010160527
- 3009144915
- 9616680
- 3036496433
- 3005180920
- 3016237080
- 3012428435
- 3004153896
- 2028632
- 2031966
- 3009049161
- 1645151
- 3006846753
- 3008110533
- 3004788213
- 3010462278
- 3003855635
- 1424434
- 3009732568
- 3031081659
- 2648623
- 3043543260
- 3006493760
- 3006217744
- 3003477135
- 1649518
- 3011127597
- 2183449
- 1530390
- 1928237
- 3004188066
- 3008959459
- 1219655
- 3013921069
- 3003597504
- 3005144609
- 3010097171
- 3031240334
- 1835296
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 |