Device Classification Name |
pin, fixation, smooth
|
510(k) Number |
K142134 |
Device Name |
C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES |
Applicant |
CONMED CORPORATION, LARGO |
11311 CONCEPT BLVD |
LARGO,
FL
33773
|
|
Applicant Contact |
JOY LOVETT |
Correspondent |
CONMED CORPORATION, LARGO |
11311 CONCEPT BLVD |
LARGO,
FL
33773
|
|
Correspondent Contact |
JOY LOVETT |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 08/04/2014 |
Decision Date | 09/12/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|