ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8011 SERIES & 1109 & 8109 SERIES

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Allen Medullary Cement Plugs, Zimmer Poly Plug Intramedullary System, Model 8011 Series & 1109 & 8109 Series.

Pre-market Notification Details

• Device ID: K001733
• 510k Number: K001733
• Device Name: ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8011 SERIES & 1109 & 8109 SERIES
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Contact: Fred Mcclure
• Correspondent: Fred Mcclure; ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Product Code: JDI
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-06-07
• Decision Date: 2000-06-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889024433021	K001733	000
00889024380196	K001733	000
00889024380202	K001733	000
00889024432918	K001733	000
00889024510326	K001733	000
00889024510333	K001733	000
00889024510340	K001733	000
00889024510357	K001733	000
00889024510364	K001733	000
00889024510371	K001733	000
00889024432970	K001733	000
00889024432987	K001733	000
00889024432994	K001733	000
00889024433007	K001733	000
00889024433014	K001733	000
00889024380189	K001733	000