ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL


Device Classification Name

plate, fixation, bone

510(k) Number K112663
Device Name ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL
Applicant
ENHATCH ORTHOPAEDICS LLC
1050 wall st
west suite 340
lyndhurst, 
NJ 
07071

Applicant Contact michael phipps
Correspondent
ENHATCH ORTHOPAEDICS LLC
1050 wall st
west suite 340
lyndhurst, 
NJ 
07071

Correspodent Contact michael phipps
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received 09/13/2011
Decision Date 03/12/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No