BONE SUTURE FIXATION DEVICE— 510(k) K880264

Name: FDA 510(k) clearance K880264
Creator: U.S. Food and Drug Administration
Published: 1988-03-23

Substantially Equivalent for Some Indications

Orthopedic Systems, Inc.

FDA 510(k) clearance K880264 for BONE SUTURE FIXATION DEVICE, Substantially Equivalent for Some Indications on 1988-03-23. Applicant: Orthopedic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Orthopedic Systems, Inc.
Product code: Code HXY
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1988-01-22
Decision date: 1988-03-23
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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