SONGER CABLE SYSTEM

Cerclage, Fixation

PIONEER SURGICAL TECHNOLOGY

The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Songer Cable System.

Pre-market Notification Details

• Device ID: K941213
• 510k Number: K941213
• Device Name: SONGER CABLE SYSTEM
• Classification: Cerclage, Fixation
• Applicant: PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855
• Contact: Burns O Severson
• Correspondent: Burns O Severson; PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855
• Product Code: JDQ
• CFR Regulation Number: 888.3010 [🔎]
• Decision: Substantially Equivalent For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-03-09
• Decision Date: 1994-04-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840298704583	K941213	000
00840298704606	K941213	000
00840298704613	K941213	000
00840298704651	K941213	000
00840298704668	K941213	000
00840298704675	K941213	000
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00840298704569	K941213	000
00840298704545	K941213	000
00840298704347	K941213	000
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00840298704361	K941213	000
00840298704378	K941213	000
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10846468074743	K941213	000