Omnia Medical TiBrid-SA— 510(k) K203207
Substantially EquivalentOmnia Medical, LLC
FDA 510(k) clearance K203207 for Omnia Medical TiBrid-SA, Substantially Equivalent on 2020-12-23. Applicant: Omnia Medical, LLC. Device class: 2.
Clearance details
- Applicant
- Omnia Medical, LLC
- Product code
- Code OVD
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morgantown,, WV, US
Recent devices under product code OVD
view allMore clearances from Omnia Medical, LLC
view allAdverse events under product code OVD
product code OVD- Death
- 5
- Injury
- 495
- Total
- 500
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 K203207
K-number listed on FDA's recall record- Z-2556-2025 — TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
- Z-2557-2025 — TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203207.
Data sourced from openFDA. This site is unofficial and independent of the FDA.