Atlas FDA

AEQUALIS SHOULDER SYSTEM

FDA 510(k) clearance K041339 · decided 2004-06-17

Clearance details

K-number
K041339
Device name
AEQUALIS SHOULDER SYSTEM
Applicant
Tornier
Decision
Substantially Equivalent
Date received
2004-05-20
Decision date
2004-06-17
Days to decision
28 days
Clearance type
Special
Product code
KWS
Device class
2
Regulation number
888.3660
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Montbonnot, FR
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.