SPONGER CABLE SYSTEM, MODIFICATION

Cerclage, Fixation

PIONEER SURGICAL TECHNOLOGY

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

Pre-market Notification Details

• Device ID: K935481
• 510k Number: K935481
• Device Name: SPONGER CABLE SYSTEM, MODIFICATION
• Classification: Cerclage, Fixation
• Applicant: PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855
• Contact: Burns Severson
• Correspondent: Burns Severson; PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855
• Product Code: JDQ
• CFR Regulation Number: 888.3010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-09-23
• Decision Date: 1994-01-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10846468005013	K935481	000
10846468005204	K935481	000
10846468005211	K935481	000
10846468005228	K935481	000
10846468005235	K935481	000
10846468005242	K935481	000
10846468005259	K935481	000
10846468005266	K935481	000
10846468005273	K935481	000
10846468005280	K935481	000
10846468005297	K935481	000
10846468005303	K935481	000
10846468005310	K935481	000
10846468005334	K935481	000
10846468005341	K935481	000
10846468005358	K935481	000
10846468005198	K935481	000
10846468005181	K935481	000
10846468005174	K935481	000
10846468005020	K935481	000
10846468005037	K935481	000
10846468005044	K935481	000
10846468005051	K935481	000
10846468005068	K935481	000
10846468005075	K935481	000
10846468005082	K935481	000
10846468005099	K935481	000
10846468005105	K935481	000
10846468005112	K935481	000
10846468005129	K935481	000
10846468005136	K935481	000
10846468005143	K935481	000
10846468005150	K935481	000
10846468005167	K935481	000
10846468005365	K935481	000
10846468005372	K935481	000
10846468005389	K935481	000
00846468040994	K935481	000
00846468041007	K935481	000
00846468041014	K935481	000
00846468041021	K935481	000
00846468041144	K935481	000
00846468041151	K935481	000
00846468041168	K935481	000
00846468041175	K935481	000
00846468041182	K935481	000
00846468047962	K935481	000
00846468053727	K935481	000
00846468061876	K935481	000
00846468061883	K935481	000
00846468061890	K935481	000
00846468061906	K935481	000
00846468040956	K935481	000
00846468040949	K935481	000
00846468040925	K935481	000
10846468074743	K935481	000
00846468023591	K935481	000
00846468023607	K935481	000
00846468023614	K935481	000
00846468030308	K935481	000
00846468030315	K935481	000
00846468030322	K935481	000
00846468040697	K935481	000
00846468040727	K935481	000
00846468040734	K935481	000
00846468040758	K935481	000
00846468040765	K935481	000
00846468040895	K935481	000
00846468040901	K935481	000
00846468040918	K935481	000
00846468061913	K935481	000