Trident® Tritanium® PST® Acetabular Shells
FDA 510(k) clearance K142606 · decided 2015-01-26
Clearance details
- K-number
- K142606
- Device name
- Trident® Tritanium® PST® Acetabular Shells
- Applicant
- Mako Surgical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2014-09-15
- Decision date
- 2015-01-26
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Cedar Knolls, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.