Cleared Traditional

K930573 - SYNVASIVE CERAMIC SUTTING BLOCK
(FDA 510(k) Clearance)

K930573 · Synvasive Technology, Inc. · Orthopedic device

Apr 1994

Decision

427d

Days

Class 1

Risk

K930573 is an FDA 510(k) clearance for the SYNVASIVE CERAMIC SUTTING BLOCK. This device is classified as a Guide, Drill, Ligament (Class I - General Controls, product code LXI).

Submitted by Synvasive Technology, Inc. (Rancho Cordova, US). The FDA issued a Cleared decision on April 7, 1994, 427 days after receiving the submission on February 4, 1993.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K930573 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 04, 1993
Decision Date	April 07, 1994
Days to Decision	427 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF