EIDOSMED, MODEL EDG4.0
FDA 510(k) clearance K091992 · decided 2009-12-09
Clearance details
- K-number
- K091992
- Device name
- EIDOSMED, MODEL EDG4.0
- Applicant
- Eidosmed, LLC
- Decision
- Substantially Equivalent
- Date received
- 2009-07-02
- Decision date
- 2009-12-09
- Days to decision
- 160 days
- Clearance type
- Traditional
- Product code
- OOL
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Deerfield, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.