SImmetry Sacroiliac Joint Fusion System
FDA 510(k) clearance K141549 · decided 2015-01-15
Clearance details
- K-number
- K141549
- Device name
- SImmetry Sacroiliac Joint Fusion System
- Applicant
- Zyga Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-06-11
- Decision date
- 2015-01-15
- Days to decision
- 218 days
- Clearance type
- Traditional
- Product code
- OUR
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.