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Tyber Medical

United States·US-MF-000011350

Last updated September 17, 2026

Information

Country
United States
Address
83, South Commerce Way, Bethlehem, United States
LinkedIn
—
Facebook
—
Phone
+1 866-761-0933
PRRC Contact
Lisa Boyle
EUDAMED SRN
US-MF-000011350
FDA FEI Number
3017980495
DUNS Number
—

Catalogue (10381)

Page 13 of 208
DeviceModel / ReferenceRegistriesClassStatus
Fps M25-402024
FDA UDI
Class IIActive
Tyber Medical Headed Cannulated Screw Short Ø6.5mm x 70mm
FDA UDI
Class IIUnknown
LEOS Cannulated Screw System 76327044LG
FDA UDI
Class IIActive
Tyber Medical Headless Ø2.0 x 13mm Short Thread Ti (Torx)
FDA UDI
Class IIUnknown
A.L.P.S. mvX™ 770400016
EUDAMEDFDA UDI
Class IIActive
Tyber Medical 502-P2613810-S
FDA UDI
Class IIActive
Tyber Medical Headed Cannulated Screw Long Ø6.5mm x 50mm
FDA UDI
Class IIUnknown
Fps F25-008020
FDA UDI
Class IActive
Tyber Medical 302-P2811412-S
FDA UDI
Class IIActive
Sterile ACIF PEEK 810-160775
FDA UDI
Class IIActive
A.L.P.S. mvX™ 770700200
FDA UDI
Class IIActive
Fps M25-251012
FDA UDI
Class IIActive
Tyber Medical 302-P2411812-S
FDA UDI
Class IIActive
Tyber Medical 302-P26708-S
FDA UDI
Class IIActive
Headed Screw System Instruments 009-000048
FDA UDI
Class IActive
Headless Screw System 401-20224
FDA UDI
Class IIActive
Cannulated Screw System + 04.355.528S
FDA UDI
Class IIActive
Snap-Off Screw System 410-20340
FDA UDI
Class IIActive
Headless Screw System 401-20440
FDA UDI
Class IIActive
Tyber Medical 502-P28848-S
FDA UDI
Class IIActive
TPLIF Interbody System M2-P2412810-S
FDA UDI
Class IIActive
Tyber Medical 302-P2216412-S
FDA UDI
Class IIActive
Riptide 6ZBZC2505
FDA UDI
Class IIActive
Cannulated Compression Headless Screw 1ZB654115
FDA UDI
Class IIActive
Tyber Medical 26-040815
FDA UDI
Class IIActive
Tyber Medical 502-T2614023-S
FDA UDI
Class IIActive
Tyber Medical Headless Ø6.5 x 150mm Full Thread Ti (Torx)
FDA UDI
Class IIActive
Tyber Medical P-281009-0
FDA UDI
Class IIActive
Tyber Medical 302-P321628-S
FDA UDI
Class IIActive
ACP System Instruments 20-GC-00013
FDA UDI
Class IActive
Cannulated Compression Headless Screw 1ZB503100
FDA UDI
Class IIActive
Tyber Medical 302-P2215012-S
FDA UDI
Class IIActive
Snap-Off Screw System 410-25234
FDA UDI
Class IIActive
LEOS Cannulated Screw System 76308833
FDA UDI
Class IActive
Snap-Off Screw System 410-30212
FDA UDI
Class IIActive
Headless Screw System 401-20420
FDA UDI
Class IIActive
Headless Screw System Instruments 001-000055
FDA UDI
Class IUnknown
Orion Headless Screw HTR-04-300422
FDA UDI
Class IIActive
ACIS® ProTi 360™ HL 208843322
FDA UDI
Class IIActive
ACIS® ProTi 360°™ 108843311
FDA UDI
Class IIActive
Tyber Medical Headed Cannulated Screw Short Ø1.5mm x 8mm
FDA UDI
Class IIActive
Cannulated Compression Headless Screw 1ZB653130
FDA UDI
Class IIActive
LEOS Cannulated Screw System 76344032SH
FDA UDI
Class IIActive
Snap-Off Screw System 410-30215
FDA UDI
Class IIActive
Fps M25-352019
FDA UDI
Class IIActive
TPLIF Interbody System M2-P2413810-S
FDA UDI
Class IIActive
LEOS Cannulated Screw System 76315570SH
FDA UDI
Class IIActive
Tyber Medical 502-P3215012-S
FDA UDI
Class IIActive
Sterile ACIF PEEK 810-140775
FDA UDI
Class IIActive
A.L.P.S. mvX™ 770270028
EUDAMEDFDA UDI
Class IIActive

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Notified Bodies

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Authorities

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FDA Recalls (20)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Dec 19, 2025Z-1131-2026—open, classified

The supplier manufactured anatomical left plates with an incorrect thread orientation.

Dec 19, 2025Z-1132-2026—open, classified

The supplier manufactured anatomical left plates with an incorrect thread orientation.

Jan 21, 2025Z-1214-2025—open, classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

Jan 21, 2025Z-1209-2025—open, classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

Jan 21, 2025Z-1223-2025—open, classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

Jan 21, 2025Z-1226-2025—open, classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

Jan 21, 2025Z-1211-2025—open, classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

Jan 21, 2025Z-1225-2025—open, classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

Jan 21, 2025Z-1216-2025—open, classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

Jan 21, 2025Z-1213-2025—open, classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

Jan 21, 2025Z-1224-2025—open, classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

Jan 21, 2025Z-1210-2025—open, classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

Jan 21, 2025Z-1219-2025—open, classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

Jan 21, 2025Z-1217-2025—open, classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

Jan 21, 2025Z-1218-2025—open, classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

Jan 21, 2025Z-1222-2025—open, classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

Jan 21, 2025Z-1220-2025—open, classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

Jan 21, 2025Z-1212-2025—open, classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

Jan 21, 2025Z-1215-2025—open, classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

Jan 21, 2025Z-1221-2025—open, classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices