510(k) K103712

GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD by Depuy Mitek, A Johnson & Johnson Company — Product Code HWC

K103712 is an FDA 510(k) premarket notification submitted by Depuy Mitek, A Johnson & Johnson Company for the device "GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD". The FDA issued a decision of Substantially Equivalent on Mar 11, 2011. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Depuy Mitek, A Johnson & Johnson Company has 61 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 11, 2011
Date Received
Dec 20, 2010
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
510(k)

Source: FDA 510(k) database entry for K103712. Report a data issue: hello@regdatalab.com.