MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K080258
Device Name MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
Applicant
ENDIUS, INC.
23 west bacon st.
plainville, 
MA 
02762

Applicant Contact regina wagner
Correspondent
ENDIUS, INC.
23 west bacon st.
plainville, 
MA 
02762

Correspodent Contact regina wagner
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received 01/31/2008
Decision Date 03/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No