510(k) K161809
- Device
- ShurFit CpTi-HA ACIF Interbody Fusion System
- Applicant
- Precision Spine, Inc.
- 510(k) number
- K161809
- Product code
- ODP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-12-06
- Date received
- 2016-07-01
- 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
- Michael C. Dawson
- Address
- 2050 Executive Dr.. Pear MS US 39208 39208
FDA Registration Numbers#
- 3009217531
- 3005497913
- 3016244279
- 3010047454
- 3006639944
- 3009129735
- 1226544
- 9681465
- 1833986
- 3009923578
- 3021180147
- 3015398319
- 3006783837
- 1000461041
- 3005819474
- 3019767615
- 3003477135
- 3004893332
- 1060840
- 3012447612
- 3023138345
- 3010763958
- 3019878714
- 3005031160
- 3007334927
- 3013055499
- 3007604895
- 3008599979
- 3013491327
- 3017565094
- 3010326971
- 3018094310
- 1043214
- 3003855635
- 3003525643
- 3008959459
- 3007441485
- 3010370500
- 3011683674
- 3009538923
- 3010123206
- 3008583793
- 1225492
- 3008992889
- 1720929
- 1835296
- 3006791286
- 3021588295
- 3004142400
- 1423662
- 3012966183
- 3009887475
- 3007279845
- 3010531060
- 3006128100
- 1319660
- 1828464
- 3016438694
- 3010120104
- 3010663372
- 3040266825
- 3010197239
- 3008864603
- 3019356409
- 3004788213
- 9617544
- 9617297
- 3005596514
- 3036756245
- 3008526708
- 3010049501
- 3016112537
- 3000170817
- 3005032068
- 3007675554
- 3004638532
- 3011556898
- 3005061536
- 3003597504
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 |
Legacy Summary#
summary
FDA Review#
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