LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE,

Plate, Fixation, Bone

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Lateral Column Length Plate, Model 824073000-3, Locked Fusion Plate, Model 824077010, Compression Fusion Plate,.

Pre-market Notification Details

• Device ID: K091294
• 510k Number: K091294
• Device Name: LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE,
• Classification: Plate, Fixation, Bone
• Applicant: DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Contact: Suzana Otano
• Correspondent: Suzana Otano; 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: 2009-05-04
• Decision Date: 2009-07-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887868049774	K091294	000
00887868445552	K091294	000
00887868445545	K091294	000
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00887868445569	K091294	000
00887868044656	K091294	000
00887868049712	K091294	000
00887868049705	K091294	000
00887868049699	K091294	000
00887868049682	K091294	000
00887868048821	K091294	000
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00887868048753	K091294	000
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00887868044687	K091294	000
00887868551277	K091294	000