AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45


Device Classification Name

screw, fixation, bone

510(k) Number K081011
Device Name AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45
Applicant
AREX USA
1335 merrybrook rd.
collegeville, 
PA 
19426

Applicant Contact ellen hokanson
Correspondent
AREX USA
1335 merrybrook rd.
collegeville, 
PA 
19426

Correspodent Contact ellen hokanson
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 04/09/2008
Decision Date 11/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No