ADDPLUS

Spinal Vertebral Body Replacement Device

ULRICH GMBH & CO. KG

The following data is part of a premarket notification filed by Ulrich Gmbh & Co. Kg with the FDA for Addplus.

Pre-market Notification Details

• Device ID: K090841
• 510k Number: K090841
• Device Name: ADDPLUS
• Classification: Spinal Vertebral Body Replacement Device
• Applicant: ULRICH GMBH & CO. KG 754 SPIRIT 40 PARK DRIVE Chesterfield, MO 63005
• Contact: Merle Symes
• Correspondent: Merle Symes; ULRICH GMBH & CO. KG 754 SPIRIT 40 PARK DRIVE Chesterfield, MO 63005
• Product Code: MQP
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-03-27
• Decision Date: 2009-10-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04052536090570	K090841	000
04052536002443	K090841	000
04052536002450	K090841	000
04052536002467	K090841	000
04052536002474	K090841	000
04052536002481	K090841	000
04052536002498	K090841	000
04052536002504	K090841	000
04052536002511	K090841	000
04052536002528	K090841	000
04052536002535	K090841	000
04052536006830	K090841	000
04052536006847	K090841	000
04052536006854	K090841	000
04052536009350	K090841	000
04052536009367	K090841	000
04052536009374	K090841	000
04052536009381	K090841	000
04052536002436	K090841	000