OGmend Implant System
FDA 510(k) clearance DEN180065 · decided 2020-05-01
Clearance details
- K-number
- DEN180065
- Device name
- OGmend Implant System
- Applicant
- Woven Orthopedic Technologies, LLC
- Decision
- Unknown
- Date received
- 2018-12-13
- Decision date
- 2020-05-01
- Days to decision
- 505 days
- Clearance type
- Direct
- Product code
- QAC
- Device class
- 2
- Regulation number
- 888.3043
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Manchester, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.