PULLUP® Adjustable Juxtacortical Fixation Device

Fastener, Fixation, Nondegradable, Soft Tissue

SBM SCIENCES FOR BIO MATERIALS

The following data is part of a premarket notification filed by Sbm Sciences For Bio Materials with the FDA for Pullup® Adjustable Juxtacortical Fixation Device.

Pre-market Notification Details

• Device ID: K151004
• 510k Number: K151004
• Device Name: PULLUP® Adjustable Juxtacortical Fixation Device
• Classification: Fastener, Fixation, Nondegradable, Soft Tissue
• Applicant: SBM SCIENCES FOR BIO MATERIALS ZI DU MONGE Lourdes, FR 65100
• Contact: Denis Clement
• Correspondent: Denis Clement; SBM SCIENCES FOR BIO MATERIALS ZI DU MONGE Lourdes, FR 65100
• Product Code: MBI
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-04-15
• Decision Date: 2015-11-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00818614020709	K151004	000
03760304680182	K151004	000
03760304680175	K151004	000
03760304680168	K151004	000
03760304680151	K151004	000
03760304680144	K151004	000
03760304680137	K151004	000
03760304680106	K151004	000
03760154008952	K151004	000
03760154007122	K151004	000
03760304680199	K151004	000
03760304680205	K151004	000
03760304680212	K151004	000
B04816104120	K151004	000
03760154008976	K151004	000
03760154008969	K151004	000
03760154006323	K151004	000
03760154006316	K151004	000
03760304680519	K151004	000
03760304680502	K151004	000
03760304680236	K151004	000
03760304680229	K151004	000
03760154007115	K151004	000