MAXIMA ANTERIOR CERVICAL PLATE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

U&I CORP.

The following data is part of a premarket notification filed by U&i Corp. with the FDA for Maxima Anterior Cervical Plate System.

Pre-market Notification Details

• Device ID: K061002
• 510k Number: K061002
• Device Name: MAXIMA ANTERIOR CERVICAL PLATE SYSTEM
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: U&I CORP. 529-1 YONGHYUN-DONG Euijungbu, Kyunggi-do, KR 480-050
• Contact: Betty Lim
• Correspondent: Betty Lim; U&I CORP. 529-1 YONGHYUN-DONG Euijungbu, Kyunggi-do, KR 480-050
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-04-11
• Decision Date: 2006-11-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08800015912341	K061002	000
08800015912211	K061002	000
08800015912204	K061002	000
08800015912198	K061002	000
08800015912181	K061002	000
08800015912174	K061002	000
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08800015912143	K061002	000
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08800015912129	K061002	000
08800015912228	K061002	000
08800015912235	K061002	000
08800015912334	K061002	000
08800015912327	K061002	000
08800015912310	K061002	000
08800015912303	K061002	000
08800015912297	K061002	000
08800015912280	K061002	000
08800015912273	K061002	000
08800015912266	K061002	000
08800015912259	K061002	000
08800015912242	K061002	000
08800015912112	K061002	000
08800015912105	K061002	000
08800015912099	K061002	000
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08800015911948	K061002	000
08800015911931	K061002	000
08800015911924	K061002	000
08800015911917	K061002	000
08800015911900	K061002	000
08800015911894	K061002	000
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08800015911870	K061002	000
08800015911979	K061002	000
08800015911986	K061002	000
08800015912082	K061002	000
08800015912075	K061002	000
08800015912068	K061002	000
08800015912051	K061002	000
08800015912044	K061002	000
08800015912037	K061002	000
08800015912020	K061002	000
08800015912013	K061002	000
08800015912006	K061002	000
08800015911993	K061002	000
08800015911863	K061002	000
08800015912358	K061002	000
08800015912846	K061002	000
08800015912716	K061002	000
08800015912709	K061002	000
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08800015912815	K061002	000
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08800015912761	K061002	000
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08800015912600	K061002	000
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08800015912556	K061002	000
08800015912549	K061002	000
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08800015912501	K061002	000
08800015912495	K061002	000
08800015912365	K061002	000