510(k) K070347

ALLOFIX PUSH-IN ANCHOR by Musculoskeletal Transplant Foundation — Product Code HWC

K070347 is an FDA 510(k) premarket notification submitted by Musculoskeletal Transplant Foundation for the device "ALLOFIX PUSH-IN ANCHOR". The FDA issued a decision of Substantially Equivalent on May 11, 2007. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Musculoskeletal Transplant Foundation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2007
Date Received
February 6, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type