Office of Device Evaluation (ODE) Fiscal Year 2006 and Fiscal Year 2007 Annual Report

www.fda.gov | Jun 20, 2008

ODE Program Operations Staff ODE Review Divisions ODE Program Management Office OMO Division of Planning, Analysis and Finance OMO Division of Information Technology Management

http://www.fda.gov/cdrh/annual/fy2007/ode/

Osteotech Receives FDA Clearance for Plexur M(TM) Biocomposite

www.prnewswire.com | Mar 4, 2008

EATONTOWN, N.J., March 4 /PRNewswire-FirstCall/ -- Osteotech, Inc. (Nasdaq: OSTE), a leader in the emerging field of biologic solutions for regenerative medicine, announced today that the Food and Drug Administration ("FDA") has cleared its 510(k) submission for its Plexur M(TM) Biocomposite.

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109&STORY=/www/story/03-04-2008/0004767728&EDATE=

Drug Law Weekly (2005-12-27) | NewsRx

Aptuit, Inc. - Drug development support company names Paul Lubetkin as general counsel Axis-Shield plc - New program to develop biosensors for diagnosis of infectious diseases Bio3 Research S.r.l.

http://www.newsrx.com/newsletters/Drug-Law-Weekly/2005-12-27.html

RTI Biologics, Inc. - Demineralization

RTI Biologics processes bone paste implants, starting with demineralized bone that has been tested in vivo for bone formation*. Moisture is removed, and the bone paste is mixed with a gelatin carrier.

http://www.rtix.com/DeminProcess.aspx

Hogan & Hartson - Professionals - Peter S. Spivack

Peter has worked with numerous companies and organizations in defending grand jury investigations, as well as conducting compliance audits and internal investigations and monitoring and improving compliance programs.

http://www.hhlaw.com/psspivack

section a:

The determination of the borderline between the Medical Devices Directive 93/42/EEC (MDD) (OJ No.L 169, 12/7/93), the Active Implantable Medical Device Directive 90/385/EEC (AIMD) (OJ No.

http://www.mdevices.net/medicn.htm

Berkeley Advanced Biomaterials, Inc.

Berkeley Advanced Biomaterials Inc. (BAB) specializes in developing and manufacturing hydroxyapatite (HAP), tricalcium phosphate (TCP), and other calcium-based products.

http://www.hydroxyapatite.com/main.html