510(k) K211704
- Device
- CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Ce
- Applicant
- Orthofix, Inc.
- 510(k) number
- K211704
- Product code
- ODP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-08-31
- Date received
- 2021-06-03
- 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
- Jacki Koch
- Address
- 3451 Plano Pkwy. Lewisville TX US 75056 75056
FDA Registration Numbers#
- 3008583793
- 3006791286
- 3011577940
- 3031787625
- 3009941480
- 3004464325
- 3013055499
- 2532027
- 3010097171
- 3014967552
- 3010032903
- 3010560653
- 3010120104
- 3004638532
- 3003639920
- 3009887475
- 3007441485
- 3011301313
- 1423662
- 2133928
- 3009882675
- 3027726367
- 3006128100
- 3009106092
- 1526711
- 1319660
- 9681465
- 3037407500
- 1928237
- 3010763958
- 3007766698
- 3009189869
- 3008455034
- 2031093
- 3015183635
- 3005677016
- 9611813
- 9615021
- 3014725904
- 8010273
- 3027201862
- 3005751028
- 3005180920
- 3005031160
- 3004788213
- 9611390
- 3009962553
- 3009732568
- 3009165919
- 3016460869
- 3005823819
- 3010057495
- 3011796723
- 3009417901
- 3013921069
- 3008850074
- 3015941638
- 3014937101
- 3017528621
- 3018094310
- 3009394448
- 3010531060
- 2027062
- 2134285
- 3023138345
- 1835296
- 3010178296
- 3010363503
- 3012764194
- 3016438694
- 3006493760
- 3015426608
- 3004941535
- 3022295665
- 1000493591
- 3013961579
- 2134470
- 2183449
- 2531477
Source Documents#
Other 510(k) Records For Product Code ODP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K254061 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | 2026-01-15 |
| K252219 | Cervical Interbody and VBR Fusion System | Sync Surgical | 2026-01-14 |