Atlas FDA

OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP

FDA 510(k) clearance K912654 · decided 1991-08-16

Clearance details

K-number
K912654
Device name
OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP
Applicant
Osteonics Corp.
Decision
Substantially Equivalent
Date received
1991-06-17
Decision date
1991-08-16
Days to decision
60 days
Clearance type
Traditional
Product code
MEH
Device class
2
Regulation number
888.3353
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Allendale, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Omnifit M/S PSL Porous Coated Acetabular Shell 40MM; Stryker Orthopaedics, Uses in primary recall (Z-1046-2011)Stryker Howmedica Osteonics Corp.2011-02-07
Omnifit M/S PSL Porous Coated Acetabular Shell 42MM; Stryker Orthopaedics, Uses in primary recall (Z-1047-2011)Stryker Howmedica Osteonics Corp.2011-02-07
Omnifit M/S PSL Porous Coated Acetabular Shell 44MM; Stryker Orthopaedics, Uses in primary recall (Z-1048-2011)Stryker Howmedica Osteonics Corp.2011-02-07
Omnifit M/S PSL Porous Coated Acetabular Shell 46MM; Stryker Orthopaedics, Uses in primary recall (Z-1049-2011)Stryker Howmedica Osteonics Corp.2011-02-07
Omnifit M/S PSL Porous Coated Acetabular Shell 48MM; Stryker Orthopaedics, Uses in primary recall (Z-1050-2011)Stryker Howmedica Osteonics Corp.2011-02-07
Omnifit M/S PSL Porous Coated Acetabular Shell 50MM; Stryker Orthopaedics, Uses in primary recall (Z-1051-2011)Stryker Howmedica Osteonics Corp.2011-02-07
Omnifit M/S PSL Porous Coated Acetabular Shell 54MM; Stryker Orthopaedics, Uses in primary recall (Z-1052-2011)Stryker Howmedica Osteonics Corp.2011-02-07
Omnifit M/S PSL Shell 58 MM; Stryker Orthopaedics, Uses in primary and revision total hip recall (Z-1053-2011)Stryker Howmedica Osteonics Corp.2011-02-07
Omnifit M/S Dual Geom Shell 58 MM; Stryker Orthopaedics, Uses in primary and revision tota recall (Z-1054-2011)Stryker Howmedica Osteonics Corp.2011-02-07
Omnifit PSL M/S 3-Hole Cup, 46MM; Stryker Orthopaedics, Uses in primary and revision total recall (Z-1055-2011)Stryker Howmedica Osteonics Corp.2011-02-07
Omnifit PSL M/S 3-Hole Cup, 48MM; Stryker Orthopaedics, Uses in primary and revision total recall (Z-1056-2011)Stryker Howmedica Osteonics Corp.2011-02-07
Omnifit PSL M/S 3-Hole Cup, 50MM; Stryker Orthopaedics, Uses in primary and revision total recall (Z-1057-2011)Stryker Howmedica Osteonics Corp.2011-02-07
Omnifit PSL M/S 3-Hole Cup, 54MM; Stryker Orthopaedics, Uses in primary and revision total recall (Z-1058-2011)Stryker Howmedica Osteonics Corp.2011-02-07
Omnifit PSL M/S 3-Hole Cup, 58MM; Stryker Orthopaedics, Uses in primary and revision total recall (Z-1059-2011)Stryker Howmedica Osteonics Corp.2011-02-07