Device Classification Name |
Orthopedic Manual Surgical Instrument
|
510(k) Number |
K140414 |
Device Name |
IMBIBE NEEDLE |
Applicant |
ORTHOVITA, INC. |
77 Great Valley Parkway |
Malvern,
PA
19355
|
|
Applicant Contact |
John Urtz |
Correspondent |
ORTHOVITA, INC. |
77 Great Valley Parkway |
Malvern,
PA
19355
|
|
Correspondent Contact |
John Urtz |
Regulation Number | 888.4540
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/18/2014 |
Decision Date | 04/01/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|