ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER
FDA 510(k) clearance K042565 · decided 2005-04-11
Clearance details
- K-number
- K042565
- Device name
- ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER
- Applicant
- Ortho Development Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-21
- Decision date
- 2005-04-11
- Days to decision
- 202 days
- Clearance type
- Traditional
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Draper, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.