510(k) K171489
- Device
- Acapella Cervical Spacer System
- Applicant
- Choice Spine, LP.
- 510(k) number
- K171489
- Product code
- OVE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-10-23
- Date received
- 2017-05-22
- 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
- Kim Finch
- Address
- 400 Erin Dr. Knoxville TN US 37919 37919
FDA Registration Numbers#
- 3013462427
- 3005706667
- 3017597868
- 2648623
- 3010462278
- 3012028003
- 3011127597
- 3005819474
- 1649518
- 3009380063
- 3040266825
- 3010032903
- 3013491327
- 1424434
- 3003120897
- 3013422238
- 8020776
- 1226544
- 3007604895
- 3005739886
- 3009957608
- 3012764194
- 9611813
- 3004635447
- 3033509898
- 3008992889
- 3025603301
- 3005596514
- 3007485169
- 3007344102
- 3022295665
- 3009217531
- 3006846753
- 3016443334
- 3005497913
- 3009959868
- 3036042032
- 2134285
- 3010120326
- 3014655115
- 1526534
- 3008850074
- 1833920
- 3017528621
- 3010097171
- 3004049923
- 2028632
- 3006128100
- 3048284429
- 9611390
- 2031093
- 3009882462
- 1649379
- 3016050940
- 3010120135
- 3005031160
- 3009509485
- 3006017180
- 1833986
- 3015941638
- 3006217744
- 3009973505
- 3010120104
- 3004893332
- 3010160527
- 3018094310
- 3025602479
- 3010866843
- 3009998573
- 3010329663
- 3009973336
- 1225492
- 3007210720
- 2183449
- 3019767615
- 3003525643
- 3009189869
- 3010009693
- 3013820501
- 2090010
Source Documents#
Other 510(k) Records For Product Code OVE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K263113 | ZSAlign Cervical Interbody System | ZSFab, Inc. | 2026-10-02 |
| K262726 | NeckTune™ SA Cervical Cage | Medyssey Co., Ltd. | 2026-09-29 |
| K263049 | SABER-C System | Elevation Spine | 2026-09-23 |
| K261882 | Pisces-SC Standalone Cervical Interbody System | Osseus Fusions Systems, LLC | 2026-08-21 |
| 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 |
Legacy Summary#
summary
FDA Review#
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