510(k) DEN220033
- Device
- MISHA Knee System
- Applicant
- Moximed, Inc.
- 510(k) number
- DEN220033
- Product code
- QVV
- Decision
- Unknown (DENG)
- Decision date
- 2023-04-10
- Date received
- 2022-06-06
- Regulation
- 888.3610
- Classification name
- Medial Knee Implanted Shock Absorber
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Nancy E. Issac
- Address
- 46602 Landing Pkwy. Fremont CA US 94538 94538
FDA Registration Numbers#
- 2029275
- 3008274656
- 2953359
Source Documents#
510(k) summary PDF not indicated by FDA