OTI UNICONDULAR INTERPOSITIONAL SPACER— 510(k) K022779

Clearance details

Applicant

Osteoimplant Technology, Inc.

Product code

Code HSH

Device class

Class 2

Regulation

21 CFR 888.3590

Advisory panel

Orthopedic

Date received

2002-08-22

Decision date

2002-11-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hunt Valley, MD, US

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