Cleared Traditional

TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON

K933205 · Danek Medical, Inc. · Orthopedic
May 1994
Decision
307d
Days
Class 2
Risk

About This 510(k) Submission

K933205 is an FDA 510(k) clearance for the TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON, a Appliance, Fixation, Spinal Interlaminal (Class II — Special Controls, product code KWP), submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on May 4, 1994, 307 days after receiving the submission on July 1, 1993. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K933205 FDA.gov
FDA Decision Cleared SN
Date Received July 01, 1993
Decision Date May 04, 1994
Days to Decision 307 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code KWP — Appliance, Fixation, Spinal Interlaminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3050

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