510(k) K143214
- Device
- SCARLET® AC-T Secured Anterior Cervical Cage
- Applicant
- SPINEART
- 510(k) number
- K143214
- Product code
- OVE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-02-23
- Date received
- 2014-11-10
- Regulation
- 888.3080
- Classification name
- Intervertebral Fusion Device With Integrated Fixation, Cervical
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Franck PENNESI
- Address
- Lnternational Center Cointrin 20 Rte. De Pré-Bois Cp1813 Geneva CH 1215 1215
FDA Registration Numbers#
- 3007485169
- 2183449
- 3010120104
- 3004719693
- 3004499989
- 3008812560
- 3015876273
- 3036756245
- 3015991317
- 1000517406
- 1834379
- 3005325790
- 3013462427
- 3004961578
- 3004142400
- 3011181154
- 3010197224
- 3010120135
- 3008992889
- 3009241418
- 3005076207
- 3015212339
- 9610612
- 1835296
- 3009959868
- 3019878714
- 3012428435
- 1720929
- 3016050940
- 9681465
- 3005497913
- 3019837678
- 3003597504
- 3003855635
- 3003526896
- 3005739886
- 3009998573
- 9615800
- 3015877656
- 1649379
- 3041915189
- 3005031160
- 3016084569
- 3011795235
- 3011187779
- 3017936978
- 2532027
- 3008850074
- 3006783837
- 3012447612
- 3003477135
- 3019767615
- 1219518
- 1057425
- 3002807112
- 3012120772
- 2032098
- 3010197239
- 3010370500
- 3007210720
- 3012711663
- 3010047454
- 3006563559
- 3003525643
- 3003898943
- 3014937101
- 3008526708
- 3007728266
- 3007604895
- 3005144609
- 3009888740
- 3040266825
- 3009189869
- 3016460869
- 3000270450
- 3008864603
- 3011577940
- 2530808
- 3013055499
Source Documents#
Other 510(k) Records For Product Code OVE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261451 | ZSAlign Cervical Interbody System | ZSFab, Inc. | 2026-07-31 |
| K262094 | E3D™-C Interbody System | Evolution Spine | 2026-07-22 |
| K261279 | DeltaNEC Interbody System | Nexus Spine | 2026-06-22 |
| K252982 | CONDUIT™ ZERO-P™ VA Secured Spacer System | Avalign Technologies, Inc. | 2026-06-18 |
| K260036 | NeckTune™ 3D SA Cervical Cage | Medyssey Co, Ltd. | 2026-06-15 |
| K260660 | SABER-C System | Elevation Spine | 2026-04-27 |
| K253213 | SAGI Cervical Cage System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-20 |
| K252774 | Uni-C Cervical Cage System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-15 |
| K260038 | E3D™-C Interbody System | Evolution Spine | 2026-02-04 |
| K253876 | HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) | Globus Medical, Inc. | 2025-12-22 |
| K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA) | 4Web Medical, Inc. | 2025-12-11 |
| K250076 | Endeavor™ Stand-Alone Cervical IBF System | Innovasis | 2025-09-25 |
| K250540 | SABER-C System | Elevation Spine | 2025-08-08 |
| K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs) | Acuity Surgical Devices, LLC | 2025-07-30 |
| K251431 | FIX-C PEEK ACIF SA System | Jeil Medical Corporation | 2025-06-27 |
Legacy Summary#
summary
FDA Review#
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