PE.R.I. II KNEE FRACTURE SYSTEM

Plate, Fixation, Bone

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Pe.r.i. Ii Knee Fracture System.

Pre-market Notification Details

• Device ID: K003235
• 510k Number: K003235
• Device Name: PE.R.I. II KNEE FRACTURE SYSTEM
• Classification: Plate, Fixation, Bone
• Applicant: DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Contact: Marcia J Arentz
• Correspondent: Marcia J Arentz; DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-10-17
• Decision Date: 2000-11-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887868041143	K003235	000
00887868036934	K003235	000
00887868036972	K003235	000
00887868036989	K003235	000
00887868037009	K003235	000
00887868037054	K003235	000
00887868040733	K003235	000
00887868040740	K003235	000
00887868040757	K003235	000
00887868040764	K003235	000
00887868040771	K003235	000
00887868040788	K003235	000
00887868036927	K003235	000
00887868036903	K003235	000
00887868036897	K003235	000
00887868041662	K003235	000
00887868041754	K003235	000
00887868041938	K003235	000
00887868036910	K003235	000
00887868036941	K003235	000
00887868036958	K003235	000
00887868036965	K003235	000
00887868036996	K003235	000
00887868037030	K003235	000
00887868037047	K003235	000
00887868036880	K003235	000
00887868040795	K003235	000
00887868040801	K003235	000
00887868041020	K003235	000
00887868041945	K003235	000
00887868041952	K003235	000
00887868041969	K003235	000
00887868041976	K003235	000
00887868041983	K003235	000
00887868041990	K003235	000
00887868042003	K003235	000
00887868042010	K003235	000
00887868042027	K003235	000
00887868042034	K003235	000
00887868041013	K003235	000
00887868040986	K003235	000
00887868040955	K003235	000
00887868040818	K003235	000
00887868040825	K003235	000
00887868040832	K003235	000
00887868040849	K003235	000
00887868040856	K003235	000
00887868040863	K003235	000
00887868040870	K003235	000
00887868040887	K003235	000
00887868040894	K003235	000
00887868040900	K003235	000
00887868040924	K003235	000
00887868042041	K003235	000