OSTEOSET DBM PELLETS, MODEL 8600-48XX

Filler, Bone Void, Calcium Compound

WRIGHT MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Osteoset Dbm Pellets, Model 8600-48xx.

Pre-market Notification Details

• Device ID: K022828
• 510k Number: K022828
• Device Name: OSTEOSET DBM PELLETS, MODEL 8600-48XX
• Classification: Filler, Bone Void, Calcium Compound
• Applicant: WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002
• Contact: Roger D Brown
• Correspondent: Roger D Brown; WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002
• Product Code: MQV
• CFR Regulation Number: 888.3045 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-08-26
• Decision Date: 2004-04-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840420133656	K022828	000
00840420133625	K022828	000
00840420133618	K022828	000
00840420133601	K022828	000
00840420133595	K022828	000