EQUIVABONE

Filler, Bone Void, Calcium Compound

ETEX CORP.

The following data is part of a premarket notification filed by Etex Corp. with the FDA for Equivabone.

Pre-market Notification Details

• Device ID: K090310
• 510k Number: K090310
• Device Name: EQUIVABONE
• Classification: Filler, Bone Void, Calcium Compound
• Applicant: ETEX CORP. 38 SIDNEY ST., 3FLR THE CLARK BLDG. Cambridge, MA 02139
• Contact: Christopher Klaczyk
• Correspondent: Christopher Klaczyk; ETEX CORP. 38 SIDNEY ST., 3FLR THE CLARK BLDG. Cambridge, MA 02139
• Product Code: MQV
• CFR Regulation Number: 888.3045 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-02-06
• Decision Date: 2009-03-24
• Summary: summary