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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
510(k) Number K922211
Device Name OSTEOMED GREAT TOE SYSTEM
Applicant
Osteomed Corp.
6062 San Fernando Rd.
Glendale,  CA  91202
Applicant Contact STEVEN C PUBOLS
Correspondent
Osteomed Corp.
6062 San Fernando Rd.
Glendale,  CA  91202
Correspondent Contact STEVEN C PUBOLS
Classification Product Code
LZJ  
Date Received05/12/1992
Decision Date 11/09/1993
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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