Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K140453
Device Classification Name
Prosthesis, Finger, Constrained, Polymer
More FDA Info for this Device
510(K) Number
K140453
Device Name
Prosthesis, Finger, Constrained, Polymer
Applicant
OSTEOTEC LTD
9 SILVER BUSINESS PARK, AIRFIELD WAY
CHRISTCHURCH, DORSET BH23 3TA GB
Other 510(k) Applications for this Company
Contact
ELIZABETH CLINTON-PARKER
Other 510(k) Applications for this Contact
Regulation Number
888.3230
More FDA Info for this Regulation Number
Classification Product Code
KYJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/24/2014
Decision Date
04/17/2015
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