SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 3.5/4.5mm Lcp Medial Proximal Tibia Plates.

Pre-market Notification Details

• Device ID: K032269
• 510k Number: K032269
• Device Name: SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
• Classification: Plate, Fixation, Bone
• Applicant: SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301
• Contact: Lisa M Boyle
• Correspondent: Lisa M Boyle; SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-07-23
• Decision Date: 2003-09-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
H6792399580	K032269	000
H6794399890	K032269	000
H679439988S0	K032269	000
H6794399880	K032269	000
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H679439993S0	K032269	000
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H6792399970	K032269	000
H679239996S0	K032269	000
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H6792399950	K032269	000
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H6792399650	K032269	000
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H6792399630	K032269	000
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H6792399680	K032269	000
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H679239958S0	K032269	000