Airlock® Osteosynthesis Plate System

Plate, Fixation, Bone

NOVASTEP

The following data is part of a premarket notification filed by Novastep with the FDA for Airlock® Osteosynthesis Plate System.

Pre-market Notification Details

• Device ID: K151277
• 510k Number: K151277
• Device Name: Airlock® Osteosynthesis Plate System
• Classification: Plate, Fixation, Bone
• Applicant: NOVASTEP Espace Performance Alphasis - Batiment C1-C2 Saint Gregoire, FR 35769
• Contact: Gilles Audic
• Correspondent: Gilles Audic; NOVASTEP Espace Performance Alphasis - Batiment C1-C2 Saint Gregoire, FR 35769
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-05-14
• Decision Date: 2015-08-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03700879503288	K151277	000
03700879503110	K151277	000
03700879503127	K151277	000
03700879503134	K151277	000
03700879503141	K151277	000
03700879503158	K151277	000
03700879503165	K151277	000
03700879503172	K151277	000
03700879509525	K151277	000
03700879503219	K151277	000
03700879503226	K151277	000
03700879503233	K151277	000
03700879503240	K151277	000
03700879503257	K151277	000
03700879503264	K151277	000
03700879503271	K151277	000
03700879503103	K151277	000