Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K994161
Device Classification Name
Fastener, Fixation, Biodegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K994161
Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Applicant
SYNTHES (USA)
P.O. BOX 1766
1690 RUSSELL ROAD
PAOLI, PA 19301-1222 US
Other 510(k) Applications for this Company
Contact
SHERI L MUSGNUNG
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
MAI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/09/1999
Decision Date
07/28/2000
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