FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Omnia Medical TiBrid-SC
K Number: K212612
·
Decision Nov 15, 2022
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
161
Applicant Total
11
Review Days
455
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Basic Information
- Device Name
- Omnia Medical TiBrid-SC
- K Number
- K212612
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Omnia Medical, LLC
- Date Received
- August 17, 2021
- Decision Date
- November 15, 2022
- Product Code
- OVE
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | FDA class 2 | Orthopedic |
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Other Clearances by Omnia Medical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K242431 | Omnia Medical PsiF DNA System | Jun 6, 2025 | Substantially Equivalent |
| K240623 | Omnia Medical TiBrid-SA System | Apr 24, 2024 | Substantially Equivalent |
| K230424 | Omnia Medical Coupler-A Anterior Lumbar Plate System; Omnia Medical Coupler-L Lateral Lumbar Plate System | Apr 12, 2023 | Substantially Equivalent |
| K223321 | Omnia Medical Coupler-C Anterior Cervical Plate | Mar 13, 2023 | Substantially Equivalent |
| K203207 | Omnia Medical TiBrid-SA | Dec 23, 2020 | Substantially Equivalent |
| K192096 | Omnia Medical Trauma Screws | Feb 27, 2020 | Substantially Equivalent |
| K190363 | Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage | Feb 21, 2020 | Substantially Equivalent |
| K191778 | Omnia Medical VBR | Aug 28, 2019 | Substantially Equivalent |
| K183659 | Omnia Medical Rotary PLIF System | Feb 6, 2019 | Substantially Equivalent |
| K172323 | Omnia Medical VBR | Oct 26, 2017 | Substantially Equivalent |