Atlas FDA

Parcus Synd-EZ SS

FDA 510(k) clearance K192964 · decided 2019-11-22

Clearance details

K-number
K192964
Device name
Parcus Synd-EZ SS
Applicant
Parcus Medical, LLC
Decision
Substantially Equivalent
Date received
2019-10-23
Decision date
2019-11-22
Days to decision
30 days
Clearance type
Special
Product code
MBI
Device class
2
Regulation number
888.3040
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Sarasota, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.