Atlas FDA

STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX

FDA 510(k) clearance K021346 · decided 2002-07-02

Clearance details

K-number
K021346
Device name
STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX
Applicant
Wrightmedicaltechnologyinc
Decision
Substantially Equivalent
Date received
2002-04-29
Decision date
2002-07-02
Days to decision
64 days
Clearance type
Abbreviated
Product code
LPH
Device class
2
Regulation number
888.3358
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Arlington, TN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and recall (Z-0183-2013)Wright Medical Technology Inc2012-10-31
Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIB recall (Z-0184-2013)Wright Medical Technology Inc2012-10-31
Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lo recall (Z-0185-2013)Wright Medical Technology Inc2012-10-31

PMA approvals by this applicant

RecordFirmDate
ADCON(R)-L ADHESION CONTROL IN A BARRIER GEL (P960057/S011)Wrightmedicaltechnologyinc2000-09-27
ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S004)Wrightmedicaltechnologyinc1999-08-11
ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S008)Wrightmedicaltechnologyinc1999-06-02
ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S006)Wrightmedicaltechnologyinc1999-04-21
ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S005)Wrightmedicaltechnologyinc1999-03-18
ADCON -L ADHESION CONTROL IN A BARRIER GEL (P960057/S003)Wrightmedicaltechnologyinc1999-01-14
ADCON -L ADHESION CONTROL IN A BARRIER GEL (P960057/S002)Wrightmedicaltechnologyinc1998-11-25
ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL (P960057/S001)Wrightmedicaltechnologyinc1998-09-11