Global Modular Replacement System— 510(k) K233261
Substantially EquivalentHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
FDA 510(k) clearance K233261 for Global Modular Replacement System, Substantially Equivalent on 2023-12-08. Applicant: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. Device class: 2.
Clearance details
- Applicant
- Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
- Product code
- Code JDI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3350
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
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- K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
More clearances from Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
view allAdverse events under product code JDI
product code JDI- Death
- 65
- Injury
- 12,943
- Malfunction
- 1,681
- Total
- 14,689
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.