510(k) K120143
- Device
- ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL
- Applicant
- APOLLO SPINE
- 510(k) number
- K120143
- Product code
- ODP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-02-16
- Date received
- 2012-01-18
- Regulation
- 888.3080
- Classification name
- Intervertebral Fusion Device With Bone Graft, Cervical
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHELE LUCEY
- Address
- 128 Blye Hill Landing Newbury NH US 03255 03255
FDA Registration Numbers#
- 2183946
- 3025603301
- 3042175940
- 2245304
- 3012711663
- 1047843
- 1833506
- 9617297
- 3040266825
- 3004024955
- 3022159082
- 9610612
- 1060840
- 1221051
- 3016112537
- 2030598
- 3006639944
- 1000517406
- 3015179588
- 3011127597
- 3005076207
- 3010705004
- 1319660
- 3013422236
- 3006791286
- 1000432246
- 3010047454
- 2028632
- 3014725904
- 3010143171
- 3004188066
- 1833824
- 3036756245
- 1226544
- 3003477135
- 2032098
- 1528646
- 2031093
- 3017936978
- 3005819474
- 3007922509
- 3019767615
- 3004049923
- 1645151
- 3008864603
- 3036496433
- 3003525643
- 3008455034
- 3005596514
- 3012131184
- 1000461041
- 9611390
- 3007728266
- 3010375065
- 9616680
- 3008992889
- 3011301313
- 3009189869
- 3000170817
- 3015941638
- 3008868758
- 3019837678
- 3009051471
- 3010363503
- 3015207155
- 3003120897
- 1526534
- 3003639920
- 9615128
- 3015542154
- 1835251
- 1030489
- 3005144609
- 3014273501
- 3010663372
- 3007766698
- 3010009693
- 3006082533
- 3023752918
Source Documents#
Other 510(k) Records For Product Code ODP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252894 | aprevo® cervical interbody system | Carlsmed, Inc. | 2026-01-06 |
Legacy Summary#
summary
FDA Review#
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