INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM


Device Classification Name

prosthesis, toe, constrained, polymer

510(k) Number K022887
Device Name INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
Original Applicant
OSTEOMED CORP.
3750 realty rd.
addison, 
TX 
75001 -4311

Original Contact dawn t holdeman
Regulation Number 888.3720
Classification Product Code
KWH  
Date Received 08/30/2002
Decision Date 11/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No