ORTHO-PRO CANNULATED BONE SCREWS

Screw, Fixation, Bone

ORTHO-PRO LLC

The following data is part of a premarket notification filed by Ortho-pro Llc with the FDA for Ortho-pro Cannulated Bone Screws.

Pre-market Notification Details

• Device ID: K042310
• 510k Number: K042310
• Device Name: ORTHO-PRO CANNULATED BONE SCREWS
• Classification: Screw, Fixation, Bone
• Applicant: ORTHO-PRO LLC 1001 OAKWOOD BLVD Round Rock, TX 78681
• Contact: J.d. Webb
• Correspondent: J.d. Webb; ORTHO-PRO LLC 1001 OAKWOOD BLVD Round Rock, TX 78681
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-08-25
• Decision Date: 2004-09-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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