510(k) K152972
- Device
- Amendia Stand-Alone Cervical System
- Applicant
- AMENDIA, INC.
- 510(k) number
- K152972
- Product code
- OVE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-01-14
- Date received
- 2015-10-08
- 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
- KRISTEN ALLEN
- Address
- 1755 W. Oak Pkwy. Marietta GA US 30062 30062
FDA Registration Numbers#
- 3012711663
- 3004142400
- 3008812560
- 3016050940
- 9617544
- 3005677016
- 3011577940
- 3013820501
- 3011127597
- 3004719693
- 3005706667
- 3005497913
- 3010178296
- 3010041499
- 3008868758
- 3011795235
- 1000432246
- 3004788213
- 3010863450
- 3007922509
- 3015216945
- 3016084569
- 3027807601
- 3021180147
- 1833986
- 1423662
- 3009189869
- 3010009693
- 3004893332
- 1450662
- 9611813
- 1935627
- 3004638600
- 3009882675
- 3017597868
- 3015876273
- 3003526896
- 9615021
- 3005144609
- 3014937101
- 3009962553
- 2134285
- 3013422238
- 3009241418
- 3036756245
- 3008455034
- 3009756327
- 3008583793
- 3007485169
- 3005819474
- 3013422236
- 3008864603
- 3009504230
- 3006128100
- 1824199
- 3010041430
- 1000517406
- 3013055499
- 1720929
- 3025603301
- 3013413393
- 3022295665
- 3007728266
- 3003525643
- 3011390763
- 3009888740
- 3017936978
- 3000203391
- 2032093
- 3010120135
- 2032098
- 3018094310
- 3010560653
- 3012764194
- 2134470
- 1834379
- 3016460869
- 3016443334
- 1649518
Source Documents#
Other 510(k) Records For Product Code OVE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K251117 | Cervical Spine Truss System (CSTS) | 4Web Medical | 2025-04-25 |
| K242928 | Tesera-k SC System | Kyocera Medical Technologies, Inc. | 2025-04-10 |
Legacy Summary#
summary
FDA Review#
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