Atlas FDA

PROTEK LOW PROFILE ACETABULAR CUP

FDA 510(k) clearance K960025 · decided 1996-06-07

Clearance details

K-number
K960025
Device name
PROTEK LOW PROFILE ACETABULAR CUP
Applicant
Intermedics Orthopedics
Decision
Substantially Equivalent
Date received
1996-01-02
Decision date
1996-06-07
Days to decision
157 days
Clearance type
Traditional
Product code
JDI
Device class
2
Regulation number
888.3350
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Austin, TX, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Original M.E. Mueller" Low Profile Cup Sterile, Rx recall (Z-0235-2013)Zimmer, Inc.2012-11-06