510(k) K061498

ALLOFIX ANCHOR, 5.0 MM ANCHOR by Musculoskeletal Transplant Foundation — Product Code JDW

K061498 is an FDA 510(k) premarket notification submitted by Musculoskeletal Transplant Foundation for the device "ALLOFIX ANCHOR, 5.0 MM ANCHOR". The FDA issued a decision of Substantially Equivalent on July 6, 2006. The device falls under product code JDW (Pin, Fixation, Threaded), 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
July 6, 2006
Date Received
May 31, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Threaded
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type