Cleared Traditional

SPINALPLANE

K934336 · Synvasive Technology, Inc. · Orthopedic

Mar 1995

Decision

549d

Days

Class 1

Risk

About This 510(k) Submission

K934336 is an FDA 510(k) clearance for the SPINALPLANE, a Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (Class I — General Controls, product code HSZ), submitted by Synvasive Technology, Inc. (Rancho Cordova, US). The FDA issued a Cleared decision on March 10, 1995, 549 days after receiving the submission on September 7, 1993. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K934336 FDA.gov
FDA Decision	Cleared SN
Date Received	September 07, 1993
Decision Date	March 10, 1995
Days to Decision	549 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

Product Code	HSZ — Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4820