510(k) DEN180065
- Device
- OGmend Implant System
- Applicant
- Woven Orthopedic Technologies, LLC
- 510(k) number
- DEN180065
- Product code
- QAC
- Decision
- Unknown (DENG)
- Decision date
- 2020-05-01
- Date received
- 2018-12-13
- Regulation
- 888.3043
- Classification name
- Screw Sleeve Bone Fixation Device
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Bob Luzzi
- Address
- 63 E. Center St. Manchester CT US 06040 06040
Source Documents#
510(k) summary PDF not indicated by FDA