CROSS-OVER ACETABULAR SHELL & LINER— 510(k) K122773
Substantially EquivalentStelkast Company
FDA 510(k) clearance K122773 for CROSS-OVER ACETABULAR SHELL & LINER, Substantially Equivalent on 2012-10-09. Applicant: Stelkast Company. Device class: 2.
Clearance details
- Applicant
- Stelkast Company
- 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
- Mcmurray, PA, US
Recent devices under product code OQG
view all- K202705 — Prime and DYNASTY® Additive Manufacturing Shells
- K203472 — KMTI Hip Replacement System
- 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
More clearances from Stelkast Company
view all- K122883 — EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM
- K094035 — EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM
- K081458 — PROVEN STEM EXTENDER
- K063211 — PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT
- K051976 — PROVEN REVISION MODULAR TIBIAL TRAY
Adverse 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 →
Recalls naming K122773
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122773.
Data sourced from openFDA. This site is unofficial and independent of the FDA.