Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set

Bone Cement, Posterior Screw Augmentation

Medtronic Sofamor Danek, USA Inc.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Usa Inc. with the FDA for Medtronic Hv-r™ Bone Cement, Kyphon™ Xpede™ Bone Cement, Cd Horizon™ Fenestrated Screw Set.

Pre-market Notification Details

• Device ID: K191148
• 510k Number: K191148
• Device Name: Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set
• Classification: Bone Cement, Posterior Screw Augmentation
• Applicant: Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis, TN 38132
• Contact: Shweta Sharma
• Correspondent: Shweta Sharma; Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis, TN 38132
• Product Code: PML
• Subsequent Product Code: NDN
• Subsequent Product Code: NKB
• CFR Regulation Number: 888.3027 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-04-30
• Decision Date: 2019-09-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00763000145293	K191148	000
00763000144043	K191148	000
00763000144050	K191148	000
00763000144067	K191148	000
00763000144074	K191148	000
00763000144081	K191148	000
00763000144098	K191148	000
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00763000144111	K191148	000
00763000144128	K191148	000
00763000144135	K191148	000
00763000144142	K191148	000
00763000144289	K191148	000
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00763000144302	K191148	000
00763000144319	K191148	000
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00763000143411	K191148	000
00763000143404	K191148	000
00763000143039	K191148	000
00763000143046	K191148	000
00763000143053	K191148	000
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00763000143077	K191148	000
00763000143084	K191148	000
00763000143091	K191148	000
00763000143107	K191148	000
00763000143114	K191148	000
00763000143336	K191148	000
00763000143343	K191148	000
00763000143350	K191148	000
00763000143367	K191148	000
00763000143374	K191148	000
00763000143381	K191148	000
00763000143398	K191148	000
00763000144333	K191148	000
00763000144340	K191148	000
00763000144357	K191148	000
00763000146191	K191148	000
00763000146207	K191148	000
00763000146214	K191148	000
00763000146221	K191148	000
00763000146238	K191148	000
00763000146245	K191148	000
00763000146481	K191148	000
00763000146498	K191148	000
00763000146504	K191148	000
00763000146511	K191148	000
00763000146528	K191148	000
00763000146535	K191148	000
00763000146542	K191148	000
00763000146559	K191148	000
00763000146566	K191148	000
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00763000146184	K191148	000
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00763000144364	K191148	000
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00763000144388	K191148	000
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00763000145316	K191148	000
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00763000145392	K191148	000
00763000146146	K191148	000
00763000146153	K191148	000
00763000146160	K191148	000
00763000146580	K191148	000