AXIS 5.5 Lumbar Pedicle Screw System

Thoracolumbosacral Pedicle Screw System

Axis Orthopaedics

The following data is part of a premarket notification filed by Axis Orthopaedics with the FDA for Axis 5.5 Lumbar Pedicle Screw System.

Pre-market Notification Details

• Device ID: K180301
• 510k Number: K180301
• Device Name: AXIS 5.5 Lumbar Pedicle Screw System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Axis Orthopaedics 34355 Poppy Wood Soldotna, AK 99669
• Contact: Craig Wilcox
• Correspondent: Steve Brown; CoorsTek Medical 560 W. Golf Course Rd. Providence, UT 84332
• Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-02-02
• Decision Date: 2018-04-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B644TPS155185600	K180301	000
B644TPS155255300	K180301	000
B644TPS155255350	K180301	000
B644TPS155255400	K180301	000
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B644TPS1551200	K180301	000
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B644TPS155500160	K180301	000
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B644TPS155365450	K180301	000
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B644TPS155375300	K180301	000
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B644TPS155365300	K180301	000
B644TPS155355600	K180301	000
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B644TPS155355500	K180301	000
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B644TPS155375500	K180301	000
B644TPS155375550	K180301	000
B644TPS155390500	K180301	000
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B644TPS155445300	K180301	000
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B644TPS155445450	K180301	000
B644TPS155455300	K180301	000
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B644TPS155390400	K180301	000
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B644TPS155385500	K180301	000
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B644TPS155390300	K180301	000
B644TPS155455400	K180301	000