Review of the ReGen Menaflex

Preliminary findings and recommendations regarding FDA's review and clearance of ReGen Biologics Inc.'s submission to market a device for use in treating injuries to the meniscus (knee cartilage).

• Preliminary Report (PDF, 163KB)
• Attachments 1-3B (PDF, 78.9KB)
• Attachments 4-16 (PDF, 1.33 MB)

Transcript for FDA's Media Briefing on the FDA's Review of the ReGen Menaflex

• September 24, 2009 [pdf, 51.3 KB] Audio [5.96 MB]

Accessibility Information

Persons with disabilities having problems accessing the Attachment may contact Tina Gilliam, 301-796-5217 for assistance.