Manta Ray TDF Spacer— 510(k) K220296

Substantially Equivalent

SeaSpine Orthopedics Corporation

FDA 510(k) clearance K220296 for Manta Ray TDF Spacer, Substantially Equivalent on 2023-02-03. Applicant: SeaSpine Orthopedics Corporation.

Clearance details

Applicant
SeaSpine Orthopedics Corporation
Product code
Code ODP
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carlsbad, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code ODP

product code ODP
Injury
310
Total
310

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.