Tyber Medical Wedge System

Bone Wedge

TYBER MEDICAL LLC

The following data is part of a premarket notification filed by Tyber Medical Llc with the FDA for Tyber Medical Wedge System.

Pre-market Notification Details

• Device ID: K150394
• 510k Number: K150394
• Device Name: Tyber Medical Wedge System
• Classification: Bone Wedge
• Applicant: TYBER MEDICAL LLC 89 HEADQUARTERS PLAZA NORTH #1464 Morristown, NJ 07960
• Contact: Jeff Tyber
• Correspondent: Jeff Tyber; TYBER MEDICAL LLC 89 HEADQUARTERS PLAZA NORTH #1464 Morristown, NJ 07960
• Product Code: PLF
• Subsequent Product Code: HRS
• Subsequent Product Code: HWC
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-02-18
• Decision Date: 2015-07-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M695TOEVNW227PS0	K150394	000
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M695TOCOTW154PS0	K150394	000
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M695TOEVNW2211PS0	K150394	000
M695TOEVNW209PS0	K150394	000
M695TOEVNW207PS0	K150394	000
M695TOEVNW2011PS0	K150394	000
M695TOEVNW189PS0	K150394	000
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M695TOCOTW197PS0	K150394	000
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M695TOCOTW157PS0	K150394	000
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M6951407060	K150394	000
M6951407050	K150394	000
M69514T0710S0	K150394	000
M69514T0709S0	K150394	000
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M69514T0708S0	K150394	000
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M69514T0706S0	K150394	000
00819917028140	K150394	000
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M69514T0705S0	K150394	000
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M695140705S0	K150394	000
00819917028188	K150394	000
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M695TOEVNW229PS0	K150394	000