BONESOURCE HAC
FDA 510(k) clearance K021440 · decided 2002-08-02
Clearance details
- K-number
- K021440
- Device name
- BONESOURCE HAC
- Applicant
- Stryker Instruments
- Decision
- Substantially Equivalent
- Date received
- 2002-05-06
- Decision date
- 2002-08-02
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- GXP
- Device class
- 2
- Regulation number
- 882.5300
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.