Cleared Traditional

CRADLE FIXATION DEVICE

K941772 · Neoligaments, Ltd. · Orthopedic
Aug 1995
Decision
483d
Days
Class 2
Risk

About This 510(k) Submission

K941772 is an FDA 510(k) clearance for the CRADLE FIXATION DEVICE, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Neoligaments, Ltd. (Leeds, GB). The FDA issued a Cleared decision on August 7, 1995, 483 days after receiving the submission on April 11, 1994. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K941772 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1994
Decision Date August 07, 1995
Days to Decision 483 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

Device Classification

Product Code JDR — Staple, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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