Atlas FDA

DOUBLE BALL JOINT

FDA 510(k) clearance K803166 · decided 1981-01-09

Clearance details

K-number
K803166
Device name
DOUBLE BALL JOINT
Applicant
Howmedica Corp.
Decision
Substantially Equivalent
Date received
1980-12-15
Decision date
1981-01-09
Days to decision
25 days
Clearance type
Traditional
Product code
JEC
Device class
2
Regulation number
888.3040
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Walker, MI, 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