Atlas FDA

DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS

FDA 510(k) clearance K972792 · decided 1997-10-16

Clearance details

K-number
K972792
Device name
DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS
Applicant
Howmedica Corp.
Decision
Substantially Equivalent
Date received
1997-07-28
Decision date
1997-10-16
Days to decision
80 days
Clearance type
Traditional
Product code
JDI
Device class
2
Regulation number
888.3350
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Rutherford, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
SURGICAL SIMPLEX P BONE CEMENT (N17004/S013)Howmedica Corp.2000-12-15
SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012)Howmedica Corp.2000-06-20
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011)Howmedica Corp.1998-03-18
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010)Howmedica Corp.1997-11-13
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009)Howmedica Corp.1997-08-08
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008)Howmedica Corp.1996-12-18
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005)Howmedica Corp.1995-11-21
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006)Howmedica Corp.1995-02-24