PARAMOUNT R IBF DEVICE

Intervertebral Fusion Device With Bone Graft, Lumbar

THEKEN SPINE LLC

The following data is part of a premarket notification filed by Theken Spine Llc with the FDA for Paramount R Ibf Device.

Pre-market Notification Details

• Device ID: K103228
• 510k Number: K103228
• Device Name: PARAMOUNT R IBF DEVICE
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: THEKEN SPINE LLC 1800 TRIPLETT BLVD. Akron, OH 44306
• Contact: Dale Davison
• Correspondent: Dale Davison; THEKEN SPINE LLC 1800 TRIPLETT BLVD. Akron, OH 44306
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-11-02
• Decision Date: 2011-01-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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