Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K003077
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K003077
Device Name
Screw, Fixation, Bone
Applicant
BIONX IMPLANTS, LTD.
1777 SENTRY PARKWAY WEST
BLUEBELL, PA 19422 US
Other 510(k) Applications for this Company
Contact
GERARD S CARLOZZI
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/03/2000
Decision Date
04/26/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact