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Home Spine Industry Forum CE & FDA

CE & FDA

The FDA and The European MDD makes it mandatory to fulfill product safety and efficacy requirements in order to market medical devices.
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Topics Started Last Post Posts Views

Interventional Spine®, Inc. Announces Issuance of Patent Covering the Company's Expandable Interbody Fusion Device, the Opticage(TM)

February 6, 2012
11:09 by
Akillas

February 6, 2012
11:09 by
Akillas

 1 21

Covidien Contraindicates the Use of Duet TRS(TM) for Thoracic Surgery, Implements a Voluntary Recall

January 20, 2012
09:29 by
Akillas

January 20, 2012
09:29 by
Akillas

 1 39

Soteira Inc., Obtains 510(k) Clearance for Shield Kyphoplasty System

December 14, 2011
09:57 by
Akillas

December 14, 2011
09:57 by
Akillas

 1 155

X-spine Announces FDA Clearance of New Spinal Implant System for Treatment of Disk Disease

December 9, 2011
16:09 by
Akillas

December 9, 2011
16:09 by
Akillas

 1 25

LDR Announces FDA Clearance of the ROI-A Oblique ALIF Cage

November 3, 2011
09:47 by
Akillas

November 3, 2011
09:47 by
Akillas

 1 48

Spinal USA Gets FDA Approval for Two New Spinal Treatment Products

October 29, 2011
20:13 by
Akillas

October 29, 2011
20:13 by
Akillas

 1 27

Spineology Receives FDA Clearance for Rampart™ Interbody Fusion System

October 18, 2011
21:10 by
Akillas

October 18, 2011
21:10 by
Akillas

 1 26

Alphatec Spine Announces Successful Resolution of FDA Warning Letter

October 7, 2011
10:57 by
Akillas

October 7, 2011
10:57 by
Akillas

 1 31

Medtronic's Omar Ishrak: FDA should embrace the European device approach

October 6, 2011
17:18 by
Akillas

October 6, 2011
17:18 by
Akillas

 1 24

Medtronic Announces 510(k) Clearance for the TSRH(R) Spinal System Pedicle Screw for the Treatment of Adolescent Idiopathic Scoliosis

September 16, 2011
10:44 by
Akillas

September 16, 2011
10:44 by
Akillas

 1 37

Zimmer Receives Pediatric Clearance for Universal Clamp Spinal Fixation System

September 15, 2011
10:08 by
Akillas

September 15, 2011
10:08 by
Akillas

 1 46

Covidien Announces DuraSeal™ Exact Spine Sealant Receives FDA Approval

September 2, 2011
11:32 by
Akillas

September 2, 2011
11:32 by
Akillas

 1 34
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