Amendia Stand-Alone Cervical System— 510(k) K152972
Substantially EquivalentAmendia, Inc.
FDA 510(k) clearance K152972 for Amendia Stand-Alone Cervical System, Substantially Equivalent on 2016-01-14. Applicant: Amendia, Inc.. Device class: 2.
Clearance details
- Applicant
- Amendia, Inc.
- Product code
- Code OVE
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marietta, GA, US
Recent devices under product code OVE
view allMore clearances from Amendia, Inc.
view allAdverse events under product code OVE
product code OVE- Injury
- 293
- Malfunction
- 710
- Total
- 1,003
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K152972
K-number listed on FDA's recall record- Z-0316-2018 — Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System.
- Z-0966-2017 — Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at the one level from C2-T1.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152972.
Data sourced from openFDA. This site is unofficial and independent of the FDA.