Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly— 510(k) K173104
Substantially EquivalentTotal Joint Orthopedics, Inc.
FDA 510(k) clearance K173104 for Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly, Substantially Equivalent on 2017-10-27. Applicant: Total Joint Orthopedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Total Joint Orthopedics, Inc.
- Product code
- Code OQG
- Device class
- Class 2
- Regulation
- 21 CFR 888.3358
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Salt Lake City, UT, US
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More clearances from Total Joint Orthopedics, Inc.
view allAdverse events under product code OQG
product code OQG- Injury
- 249
- Total
- 249
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.