BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE

Bone Grafting Material, Synthetic

INTEGRA LIFESCIENCES CORP.

The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen Menbrane.

Pre-market Notification Details

• Device ID: K992216
• 510k Number: K992216
• Device Name: BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE
• Classification: Bone Grafting Material, Synthetic
• Applicant: INTEGRA LIFESCIENCES CORP. 105 MORGAN LN. Plainsboro, NJ 08536
• Contact: Judith E O'grady
• Correspondent: Judith E O'grady; INTEGRA LIFESCIENCES CORP. 105 MORGAN LN. Plainsboro, NJ 08536
• Product Code: LYC
• CFR Regulation Number: 872.3930 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-07-01
• Decision Date: 1999-07-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841336100879	K992216	000
30381780070768	K992216	000
30381780070782	K992216	000
30381780038515	K992216	000
30381780038522	K992216	000
30381780038539	K992216	000
30381780072601	K992216	000
30381780072618	K992216	000
30381780072625	K992216	000
00841336100855	K992216	000
00841336100862	K992216	000
30381780070744	K992216	000