Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly
FDA 510(k) clearance K173104 · decided 2017-10-27
Clearance details
- K-number
- K173104
- Device name
- Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly
- Applicant
- Total Joint Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-09-29
- Decision date
- 2017-10-27
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- OQG
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.