SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220,2221,22


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K992369
Device Name SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220,2221,22
Applicant
INTERPORE CROSS INTL.
181 technology dr.
irvine, 
CA 
92618 -2402

Applicant Contact lynn m rodarti
Correspondent
INTERPORE CROSS INTL.
181 technology dr.
irvine, 
CA 
92618 -2402

Correspodent Contact lynn m rodarti
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   KWQ   MNH  
Date Received 07/15/1999
Decision Date 10/13/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No