Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System
FDA 510(k) clearance K182468 · decided 2019-03-19
Clearance details
- K-number
- K182468
- Device name
- Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System
- Applicant
- Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
- Decision
- Substantially Equivalent
- Date received
- 2018-09-10
- Decision date
- 2019-03-19
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- 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.