STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT)


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K111478
Device Name STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT)
Applicant
STRYKER CORPORATION
2 pearl court
allendale, 
NJ 
07401

Applicant Contact tiffani rogers
Correspondent
STRYKER CORPORATION
2 pearl court
allendale, 
NJ 
07401

Correspodent Contact tiffani rogers
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received 05/27/2011
Decision Date 08/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No