KMTI Hip Replacement System— 510(k) K203472
Substantially EquivalentKyocera Medical Technologies, Inc.
FDA 510(k) clearance K203472 for KMTI Hip Replacement System, Substantially Equivalent on 2021-04-02. Applicant: Kyocera Medical Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Kyocera Medical Technologies, 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
- Redlands, CA, US
Recent devices under product code OQG
view all- K202705 — Prime and DYNASTY® Additive Manufacturing Shells
- K201660 — KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
- K200328 — Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
- K172651 — FMP Extended Liners
- K171543 — Renovis Surgical Hip Replacement System
More clearances from Kyocera Medical Technologies, 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.