Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment
FDA 510(k) clearance K190991 · decided 2019-08-15
Clearance details
- K-number
- K190991
- Device name
- Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment
- Applicant
- Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)
- Decision
- Substantially Equivalent
- Date received
- 2019-04-15
- Decision date
- 2019-08-15
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- MBH
- Device class
- 2
- Regulation number
- 888.3565
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mahwah, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.