KNEEALIGN SYSTEM

Orthopedic Stereotaxic Instrument

ORTHALIGN, INC

The following data is part of a premarket notification filed by Orthalign, Inc with the FDA for Kneealign System.

Pre-market Notification Details

• Device ID: K103829
• 510k Number: K103829
• Device Name: KNEEALIGN SYSTEM
• Classification: Orthopedic Stereotaxic Instrument
• Applicant: ORTHALIGN, INC 338 VISTA MADERA Newport Beach, CA 92660
• Contact: Amy Walters
• Correspondent: Amy Walters; ORTHALIGN, INC 338 VISTA MADERA Newport Beach, CA 92660
• Product Code: OLO
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-12-30
• Decision Date: 2011-04-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00810832031376	K103829	000
00858704006060	K103829	000
00858704006077	K103829	000
00858704006084	K103829	000
00858704006091	K103829	000
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00858704006176	K103829	000
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00858704006190	K103829	000
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00858704006213	K103829	000
00858704006053	K103829	000
00858704006046	K103829	000
00851977007239	K103829	000
00851977007246	K103829	000
00851977007284	K103829	000
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00851977007307	K103829	000
00851977007451	K103829	000
00851977007468	K103829	000
00851977007475	K103829	000
00851977007925	K103829	000
00851977007970	K103829	000
00851977007987	K103829	000
00851977007994	K103829	000
10858704006005	K103829	000
00858704006015	K103829	000
00858704006022	K103829	000
00858704006039	K103829	000
00858704006220	K103829	000
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00858704006435	K103829	000
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00858704006480	K103829	000
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00858704006510	K103829	000
00858704006800	K103829	000
00810832030058	K103829	000
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00810832030201	K103829	000
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00858704006350	K103829	000
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00858704006398	K103829	000
00858704006404	K103829	000
00810832030393	K103829	000