FDA.report

510(k) K022886

Device
METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
Applicant
Osteomed Corp.
510(k) number
K022886
Product code
KWH
Decision
Substantially Equivalent (SESE)
Decision date
2002-11-25
Date received
2002-08-30
Regulation
888.3720
Classification name
Prosthesis, Toe, Constrained, Polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
DAWN T HOLDEMAN
Address
3750 Realty Rd. Addison TX US 75001 75001

FDA Registration Numbers

Source Documents

510(k) summary PDF

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