ZUMA-C— 510(k) K092521
Substantially EquivalentSeaspine, Inc.
FDA 510(k) clearance K092521 for ZUMA-C, Substantially Equivalent on 2010-04-13. Applicant: Seaspine, Inc.. Device class: 2.
Clearance details
- Applicant
- Seaspine, 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
- Vista, CA, US
Recent devices under product code OVE
view allMore clearances from Seaspine, Inc.
view all- K231654 — NorthStar OCT System
- K150469 — Integra Laminoplasty System
- K142488 — SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene
- K133418 — INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM
- K132859 — INTEGRA FACET FIXATION SYSTEM
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.