Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System— 510(k) K200328
Substantially EquivalentKyocera Medical Technologies, Inc.
FDA 510(k) clearance K200328 for Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System, Substantially Equivalent on 2020-03-11. 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
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- K201660 — KMTI Hip Replacement System, 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.