Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K023013 |
Device Name |
STRYKER XCEL ANCHOR SYSTEM |
Applicant |
Stryker Endoscopy |
5900 OPTICAL CT. |
SAN JOSE,
CA
95138
|
|
Applicant Contact |
ALISA MILLER |
Correspondent |
Stryker Endoscopy |
5900 OPTICAL CT. |
SAN JOSE,
CA
95138
|
|
Correspondent Contact |
ALISA MILLER |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 09/10/2002 |
Decision Date | 02/26/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|