RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer

MAKO SURGICAL CORPORATION

The following data is part of a premarket notification filed by Mako Surgical Corporation with the FDA for Restoris Multicompartmental Knee System.

Pre-market Notification Details

• Device ID: K133039
• 510k Number: K133039
• Device Name: RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM
• Classification: Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: MAKO SURGICAL CORPORATION 2555 DAVIE ROAD Fort Lauderdale, FL 33317
• Contact: Jonathan Reeves
• Correspondent: Jonathan Reeves; MAKO SURGICAL CORPORATION 2555 DAVIE ROAD Fort Lauderdale, FL 33317
• Product Code: NPJ
• Subsequent Product Code: HRY
• Subsequent Product Code: HSX
• Subsequent Product Code: KRR
• Subsequent Product Code: OIY
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-09-26
• Decision Date: 2013-12-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00848486015152	K133039	000
00848486015343	K133039	000
00848486015350	K133039	000
00848486015367	K133039	000
00848486015374	K133039	000
00848486015381	K133039	000
00848486015398	K133039	000
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00848486015435	K133039	000
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00848486015466	K133039	000
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00848486015480	K133039	000
00848486015497	K133039	000
00848486015336	K133039	000
00848486015329	K133039	000
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00848486015183	K133039	000
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00848486015268	K133039	000
00848486015275	K133039	000
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00848486015305	K133039	000
00848486015312	K133039	000
00848486015503	K133039	000
00848486015510	K133039	000
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00848486015718	K133039	000
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00848486015749	K133039	000
00848486015756	K133039	000
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00848486015596	K133039	000
00848486015602	K133039	000
00848486015619	K133039	000
00848486015626	K133039	000
00848486015633	K133039	000
00848486015640	K133039	000
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00848486015664	K133039	000
00848486015671	K133039	000
00848486015862	K133039	000