MRS-TITAN


Device Classification Name

prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

510(k) Number K992359
Device Name MRS-TITAN
Applicant
ROTEC MEDIZINTECHNIK GMBH
am muhlberg 31
weisendorf, 

DE

d-91084

Applicant Contact ing ulrich holzwarth
Correspondent
ROTEC MEDIZINTECHNIK GMBH
am muhlberg 31
weisendorf, 

DE

d-91084

Correspodent Contact ing ulrich holzwarth
Regulation Number 888.3353
Classification Product Code
LZO  
Date Received 07/14/1999
Decision Date 02/18/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No