510(k) K142456
- Device
- GPS Spacers
- Applicant
- G SURGICAL, LLC
- 510(k) number
- K142456
- Product code
- ODP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-04-10
- Date received
- 2014-09-02
- 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
- Donald Grafton
- Address
- 5757 Central Ave., Suite G Boulder CO US 80301 80301
FDA Registration Numbers#
- 3004142400
- 3016050940
- 9617544
- 3005677016
- 3011127597
- 3008868758
- 3015216945
- 3010509633
- 3019356409
- 9611813
- 1423662
- 3010009693
- 1836116
- 3009882675
- 3009106092
- 3005144609
- 3011513267
- 3009381600
- 3009504230
- 1000517406
- 3013055499
- 3007728266
- 3011390763
- 2032093
- 3012764194
- 3005032068
- 3005596514
- 3009826895
- 3031240334
- 3006563559
- 3004049923
- 3023189283
- 3010363503
- 3015941638
- 3017435639
- 3014019090
- 3015151147
- 2031966
- 1424434
- 1528646
- 1530390
- 1649379
- 3014655115
- 3021945817
- 1000493591
- 1834331
- 3003761012
- 1221051
- 3003855635
- 3010287685
- 3014725904
- 3006487372
- 3012994232
- 1529009
- 3009973505
- 9681465
- 3031081659
- 3015440604
- 3018210489
- 3009882462
- 3008850074
- 1054811
- 3009973336
- 3010462278
- 3005325790
- 3003678543
- 2029275
- 3010120326
- 3010047454
- 2531477
- 3009049161
- 3009051471
- 3012711663
- 3010663372
- 3027807601
- 3021180147
- 3009189869
- 3006082533
- 1935627
Source Documents#
Other 510(k) Records For Product Code ODP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252711 | Advantage-C™ Ti3D Cervical Interbody Fusion Device | Intelivation Technologies | 2026-01-08 |
Legacy Summary#
summary
FDA Review#
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