510(k) K200052
- Device
- CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System
- Applicant
- Orthofix Inc.
- 510(k) number
- K200052
- Product code
- ODP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-04-09
- Date received
- 2020-01-10
- 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
- Natalia Volosen
- Address
- 3451 Plano Pkwy. Lewisville TX US 75056 75056
FDA Registration Numbers#
- 1221051
- 3027201862
- 2245304
- 3006755626
- 3003678543
- 3009923578
- 3011390763
- 3014725904
- 3011127597
- 3005562917
- 3021006165
- 3010041430
- 3009959868
- 1530390
- 3006783837
- 3007887127
- 3015179588
- 3016237080
- 3015426608
- 3004142400
- 3000170817
- 1724955
- 3014937101
- 3015398319
- 3022159082
- 1528646
- 3004788213
- 2030598
- 3036496433
- 2531477
- 3004153896
- 1526439
- 3017980495
- 3013491327
- 3010032903
- 2027467
- 1720929
- 3005739886
- 3011181154
- 3037407500
- 1828464
- 1833506
- 3010326971
- 3007334927
- 3004774118
- 3010531060
- 3012428435
- 9617544
- 2028632
- 9681465
- 3010863450
- 3036042032
- 2530808
- 3012966183
- 3005977257
- 1000432246
- 3015941638
- 3010143171
- 3013548554
- 8010273
- 3006404071
- 3005076207
- 3010462278
- 3011796723
- 3021945817
- 3013422238
- 1833920
- 3018094310
- 3010173425
- 3008812560
- 1526534
- 3009973505
- 3036503733
- 1225492
- 3013422236
- 3010665091
- 1935627
- 3005061536
- 3016112537
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 |
| 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 |
| K250764 | SpineLinc Anterior Cervical Implant System | Lincotek Medical | 2025-12-05 |
Legacy Summary#
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FDA Review#
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