Device Classification Name |
System, Facet Screw Spinal Device
|
510(k) Number |
K043351 |
Device Name |
4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N |
Applicant |
TRIAGE MEDICAL INC |
13700 ALTON PKWY. |
SUITE 160 |
IRVINE,
CA
92618
|
|
Applicant Contact |
GAYLE HIROTA |
Correspondent |
TRIAGE MEDICAL INC |
13700 ALTON PKWY. |
SUITE 160 |
IRVINE,
CA
92618
|
|
Correspondent Contact |
GAYLE HIROTA |
Classification Product Code |
|
Date Received | 12/06/2004 |
Decision Date | 02/18/2005 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|