TENZING SYSTEM
FDA 510(k) clearance K102130 · decided 2010-08-26
Clearance details
- K-number
- K102130
- Device name
- TENZING SYSTEM
- Applicant
- Mazor Surgical Technologies , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-07-29
- Decision date
- 2010-08-26
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Kfar Saba, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.