LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S

Thoracolumbosacral Pedicle Screw System

LDR SPINE USA INC.

The following data is part of a premarket notification filed by Ldr Spine Usa Inc. with the FDA for Ldr Spine Usa Spine Tune, Tl Spinal System, Ldr Spine Usa Easyspine, Posterior Spinal System, Ldr Spine Usa Mc Implant S.

Pre-market Notification Details

• Device ID: K121103
• 510k Number: K121103
• Device Name: LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: LDR SPINE USA INC. 13785 RESEARCH BOULEVARD SUITE 200 Austin, TX 78750
• Contact: Bradley W Strasser
• Correspondent: Bradley W Strasser; LDR SPINE USA INC. 13785 RESEARCH BOULEVARD SUITE 200 Austin, TX 78750
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: MAX
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• Subsequent Product Code: MQP
• Subsequent Product Code: ODP
• Subsequent Product Code: OVD
• Subsequent Product Code: OVE
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-04-11
• Decision Date: 2012-08-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03662663036641	K121103	000
03662663042383	K121103	000
03662663042826	K121103	000
03662663042932	K121103	000
03662663043038	K121103	000
03662663043045	K121103	000
03662663043052	K121103	000
03662663043120	K121103	000
03662663043137	K121103	000
03662663043410	K121103	000
03662663043519	K121103	000
03662663043571	K121103	000
03662663043588	K121103	000
03662663043632	K121103	000
03662663043793	K121103	000
03662663043908	K121103	000
03662663044011	K121103	000
03662663044028	K121103	000
03662663042277	K121103	000
03662663042161	K121103	000
03662663036863	K121103	000
03662663040228	K121103	000
03662663040587	K121103	000
03662663040686	K121103	000
03662663041171	K121103	000
03662663041621	K121103	000
03662663041638	K121103	000
03662663041645	K121103	000
03662663041652	K121103	000
03662663041669	K121103	000
03662663041737	K121103	000
03662663041744	K121103	000
03662663041751	K121103	000
03662663041812	K121103	000
03662663041928	K121103	000
03662663042024	K121103	000
03662663042055	K121103	000
03662663044035	K121103	000
03662663044042	K121103	000
03662663044257	K121103	000
03662663044264	K121103	000
03662663044271	K121103	000
03662663044288	K121103	000
03662663044295	K121103	000
03662663044301	K121103	000
03662663044318	K121103	000
03662663044325	K121103	000
03662663044332	K121103	000
03662663045490	K121103	000
03662663045506	K121103	000
03662663042604	K121103	000
03662663042710	K121103	000
03662663043304	K121103	000
03662663043601	K121103	000
03662663043687	K121103	000
03662663044158	K121103	000
03662663044240	K121103	000
03662663044233	K121103	000
03662663044059	K121103	000
03662663044066	K121103	000
03662663044073	K121103	000
03662663044080	K121103	000
03662663044097	K121103	000
03662663044103	K121103	000
03662663044110	K121103	000
03662663044127	K121103	000
03662663044134	K121103	000
03662663044141	K121103	000
03662663044165	K121103	000
03662663044172	K121103	000
03662663044189	K121103	000
03662663044196	K121103	000
03662663044202	K121103	000
03662663044219	K121103	000
03662663044226	K121103	000
03662663042499	K121103	000