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
10846468074743	K941213	000
10846468005174	K941213	000
10846468005167	K941213	000
10846468005150	K941213	000
10846468005143	K941213	000
10846468005136	K941213	000
10846468005129	K941213	000
10846468005112	K941213	000
10846468005105	K941213	000
10846468005099	K941213	000
10846468005082	K941213	000
10846468005075	K941213	000
10846468005068	K941213	000
10846468005051	K941213	000
10846468005044	K941213	000
10846468005037	K941213	000
10846468005020	K941213	000
10846468005181	K941213	000
10846468005198	K941213	000
10846468005365	K941213	000
10846468005358	K941213	000
10846468005341	K941213	000
10846468005334	K941213	000
10846468005310	K941213	000
10846468005303	K941213	000
10846468005297	K941213	000
10846468005280	K941213	000
10846468005273	K941213	000
10846468005266	K941213	000
10846468005259	K941213	000
10846468005242	K941213	000
10846468005235	K941213	000
10846468005228	K941213	000
10846468005211	K941213	000
10846468005204	K941213	000
10846468005013	K941213	000