RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6
FDA 510(k) clearance K140904 · decided 2014-05-06
Clearance details
- K-number
- K140904
- Device name
- RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6
- Applicant
- Encore Medical L.P.
- Decision
- Substantially Equivalent
- Date received
- 2014-04-09
- Decision date
- 2014-05-06
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- PHX
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.