ABBOTT SPINE, INC. SPINNAKER SYSTEM
FDA 510(k) clearance K052638 · decided 2005-11-07
Clearance details
- K-number
- K052638
- Device name
- ABBOTT SPINE, INC. SPINNAKER SYSTEM
- Applicant
- Abbott Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-26
- Decision date
- 2005-11-07
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.