Atlas FDA

P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)

FDA 510(k) clearance K961685 · decided 1996-07-10

Clearance details

K-number
K961685
Device name
P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)
Applicant
Johnson & Johnson Professionals, Inc.
Decision
Substantially Equivalent
Date received
1996-05-01
Decision date
1996-07-10
Days to decision
70 days
Clearance type
Traditional
Product code
JWH
Device class
2
Regulation number
888.3560
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Raynham, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100. recall (Z-0057-2007)Depuy Orthopaedics, Inc.2006-10-21
Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 2.5, 8 mm; Ref 97-0340. recall (Z-1315-05)Depuy Orthopaedics, Inc.2005-08-12
Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 12.5 mm; Ref 97-0352. recall (Z-1316-05)Depuy Orthopaedics, Inc.2005-08-12
Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 15.0 mm; Ref 97-0353. recall (Z-1317-05)Depuy Orthopaedics, Inc.2005-08-12
Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 4, 10 mm; Ref 97-0361. recall (Z-1318-05)Depuy Orthopaedics, Inc.2005-08-12
Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 5, 10.0 Ref 97-0371. recall (Z-1319-05)Depuy Orthopaedics, Inc.2005-08-12
Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 5, 15.0 mm; Ref 97-0373. recall (Z-1320-05)Depuy Orthopaedics, Inc.2005-08-12