STRYKER SAGITTAL SAW ATTACHMENT— 510(k) K954483
Substantially EquivalentStryker Instruments
FDA 510(k) clearance K954483 for STRYKER SAGITTAL SAW ATTACHMENT, Substantially Equivalent on 1996-01-30. Applicant: Stryker Instruments. Device class: 1.
Clearance details
- Applicant
- Stryker Instruments
- Product code
- Product code GFA
- Device class
- Class 1
- Regulation
- 21 CFR 878.4820
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kalamazoo, MI, US
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Adverse events under product code GFA
product code GFA- Death
- 2
- Injury
- 140
- Malfunction
- 2,337
- Total
- 2,479
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.