Atlas FDA

TIE-IN TRAPEZIUM

FDA 510(k) clearance K033529 · decided 2003-12-03

Clearance details

K-number
K033529
Device name
TIE-IN TRAPEZIUM
Applicant
Wrightmedicaltechnologyinc
Decision
Substantially Equivalent
Date received
2003-11-10
Decision date
2003-12-03
Days to decision
23 days
Clearance type
Special
Product code
KYI
Device class
2
Regulation number
888.3770
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

No recalls on record reference this clearance.

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