Device Classification Name |
Screw, Fixation, Bone
|
510(k) Number |
K080358 |
Device Name |
PLLA, HA SCREW |
Applicant |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
150 MINUTEMAN RD. |
ANDOVER,
MA
01810
|
|
Applicant Contact |
DEANA BOUSHELL |
Correspondent |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
150 MINUTEMAN RD. |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
DEANA BOUSHELL |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 02/11/2008 |
Decision Date | 04/23/2008 |
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
|
|
|