Cleared Special

K012871 - SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177
(FDA 510(k) Clearance)

K012871 · Interpore Cross Intl. · Orthopedic

Sep 2001

Decision

17d

Days

Class 2

Risk

K012871 is an FDA 510(k) clearance for the SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177, a Appliance, Fixation, Spinal Interlaminal (Class II — Special Controls, product code KWP), submitted by Interpore Cross Intl. (Irvine, US). The FDA issued a Cleared decision on September 13, 2001, 17 days after receiving the submission on August 27, 2001. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number	K012871 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 27, 2001
Decision Date	September 13, 2001
Days to Decision	17 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF