MSA HIP SYSTEM
FDA 510(k) clearance K113107 · decided 2011-12-15
Clearance details
- K-number
- K113107
- Device name
- MSA HIP SYSTEM
- Applicant
- Global Manufacturing Technology
- Decision
- Substantially Equivalent
- Date received
- 2011-10-20
- Decision date
- 2011-12-15
- Days to decision
- 56 days
- Clearance type
- Special
- Product code
- MEH
- Device class
- 2
- Regulation number
- 888.3353
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.