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#
- 3013961579
- 3009962553
- 3006563559
- 3009957608
- 3008110533
- 3010047454
- 3009049161
- 1047843
- 2032521
- 3008868758
- 2028632
- 2245304
- 1928237
- 3014725904
- 3006378738
- 3010097171
- 3011301313
- 3022295665
- 2031966
- 8010273
- 3009756327
- 3007887127
- 3010560653
- 3004024955
- 3000170817
- 1220477
- 3024999441
- 3009888740
- 3003761012
- 3008583793
- 3018210489
- 3010160527
- 3017528621
- 3005031160
- 3009417901
- 3015831087
- 3012120772
- 3027807601
- 3017065977
- 3013422236
- 3005751028
- 1935627
- 1649379
- 2134285
- 1828464
- 1834331
- 1054811
- 3009941480
- 3009217531
- 3006082533
- 1030489
- 1424263
- 3015941638
- 3009051471
- 3017936978
- 3025602479
- 3007766698
- 9611390
- 3030412764
- 2032098
- 1529009
- 1833920
- 3012764194
- 3004464325
- 3012131184
- 3009106092
- 3010057495
- 3009129735
- 3004941535
- 3007675554
- 3007441485
- 3021006165
- 3016237080
- 3010120135
- 3015151147
- 3010039400
- 3002807112
- 1319660
- 3031081659
Source Documents#
Other 510(k) Records For Product Code ODP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252711 | Advantage-C™ Ti3D Cervical Interbody Fusion Device | Intelivation Technologies | 2026-01-08 |
| K252894 | aprevo® cervical interbody system | Carlsmed, Inc. | 2026-01-06 |
| K252781 | MSFX MIKRON PEEK CAGES | Mikron Makina Sanayi VE Tic. Ltd. Sti. | 2025-12-19 |