MedCAD® AccuPlate® Patient-Specific Plate

Plate, Bone

MedCAD

The following data is part of a premarket notification filed by Medcad with the FDA for Medcad® Accuplate® Patient-specific Plate.

Pre-market Notification Details

• Device ID: K193280
• 510k Number: K193280
• Device Name: MedCAD® AccuPlate® Patient-Specific Plate
• Classification: Plate, Bone
• Applicant: MedCAD 501 S 2nd Ave., Suite A-1000 Dallas, TX 75226
• Contact: Brian Buss
• Correspondent: Linda Braddon; Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188
• Product Code: JEY
• CFR Regulation Number: 872.4760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-11-27
• Decision Date: 2021-02-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00810007633091	K193280	000
00810007632957	K193280	000
00810007632940	K193280	000
00810007632933	K193280	000
00810007632865	K193280	000
00810007632858	K193280	000
00810007632841	K193280	000
00810007632834	K193280	000
00810007632827	K193280	000
00810007632964	K193280	000
00810007632971	K193280	000
00810007632995	K193280	000
00810007633077	K193280	000
00810007633060	K193280	000
00810007633053	K193280	000
00810007633046	K193280	000
00810007633039	K193280	000
00810007633022	K193280	000
00810007633015	K193280	000
00810007633008	K193280	000
00810007632810	K193280	000
00810007632803	K193280	000
00810007631790	K193280	000
00810007631783	K193280	000
00810007631776	K193280	000
00810007631769	K193280	000
00810007631752	K193280	000
00810007631745	K193280	000
00810007631738	K193280	000
00810007633084	K193280	000
00810007631806	K193280	000
00810007632049	K193280	000
00810007632056	K193280	000
00810007632797	K193280	000
00810007632780	K193280	000
00810007632773	K193280	000
00810007632766	K193280	000
00810007632759	K193280	000
00810007632742	K193280	000
00810007632735	K193280	000
00810007632728	K193280	000
00810007632988	K193280	000
00810007630588	K193280	000
00810007630458	K193280	000
00810007630410	K193280	000
00810007630984	K193280	000
00810007630977	K193280	000
00810007630960	K193280	000
00810007630953	K193280	000
00810007630946	K193280	000
00810007630939	K193280	000
00810007630465	K193280	000
00810007630472	K193280	000
00810007630489	K193280	000
00810007630571	K193280	000
00810007630564	K193280	000
00810007630557	K193280	000
00810007630540	K193280	000
00810007630526	K193280	000
00810007630519	K193280	000
00810007630502	K193280	000
00810007630496	K193280	000
00810007630922	K193280	000
00810007630915	K193280	000
00810007631127	K193280	000
00810007633176	K193280	000
00810007633169	K193280	000
00810007633152	K193280	000
00810007633145	K193280	000
00810007633138	K193280	000
00810007633121	K193280	000
00810007633114	K193280	000
00810007631134	K193280	000
00810007631141	K193280	000
00810007631486	K193280	000
00810007630908	K193280	000
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00810007630878	K193280	000
00810007631097	K193280	000
00810007631080	K193280	000
00810007631509	K193280	000
00810007631493	K193280	000
00810007633107	K193280	000