STRYKER NAVIGATION SYSTEM-KNEE MODULE
FDA 510(k) clearance K022579 · decided 2003-06-02
Clearance details
- K-number
- K022579
- Device name
- STRYKER NAVIGATION SYSTEM-KNEE MODULE
- Applicant
- Stryker Leibinger
- Decision
- Substantially Equivalent
- Date received
- 2002-08-05
- Decision date
- 2003-06-02
- Days to decision
- 301 days
- Clearance type
- Traditional
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
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