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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
Website: tybermedical.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 866-761-0933
PRRC Contact: Lisa Boyle
EUDAMED SRN: US-MF-000011350
FDA FEI Number: 3017980495
DUNS Number: —

Catalogue (10381)

Page 7 of 208

Device	Model / Reference	Registries	Class	Status
Tyber Medical	Headless Ø4.5 x 29mm Short Thread Ti (Torx)	FDA UDI	Class II	Active
Tyber Medical	Headless Ø6.5 x 120mm Full Thread Ti (Torx)	FDA UDI	Class II	Unknown
Orion Headed Screw	HTR-04-654955	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76357048LG	FDA UDI	Class II	Active
Tyber Medical	502-P309012-S	FDA UDI	Class II	Active
ACIS® ProTi 360™ HL	208843344	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76345550SH	FDA UDI	Class II	Active
Tyber Medical	Headless Ø2.0 x 38mm Short Thread Ti (Torx)	FDA UDI	Class II	Active
Tyber Medical	Headless Ø2.0 x 19mm Long Thread Ti (Torx)	FDA UDI	Class II	Active
Tyber Medical	Headless Ø3.0 x 20mm Full Thread Ti (Torx)	FDA UDI	Class II	Unknown
Tyber Medical	Headed Cannulated Screw Short Ø6.5mm x 52mm	FDA UDI	Class II	Unknown
Tyber Medical	302-P221648-S	FDA UDI	Class II	Active
CONCORDE® ProTi 360°™	188835212	FDA UDI	Class II	Active
Tyber Medical	502-P2412410-S	FDA UDI	Class II	Active
1.5 / 2.0 / 3.0 Trauma Screw Tray Instruments	001-000025	FDA UDI	Class I	Active
Tyber Medical	502-P3016212-S	FDA UDI	Class II	Active
Fps	M25-402036	FDA UDI	Class II	Active
Tyber Medical	302-P2813812-S	FDA UDI	Class II	Active
Tyber Medical	502-P2210010-S	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB50444	FDA UDI	Class II	Active
Tyber Medical	Headless Ø2.0 x 10mm Long Thread Ti (Torx)	FDA UDI	Class II	Unknown
ACIS® ProTi 360°™	108843811	FDA UDI	Class II	Active
Orion Headed Screw System Instruments	HTR-04-009143	FDA UDI	Class I	Active
Fps	M25-712251	FDA UDI	Class II	Active
Tyber Medical	302-P321608-S	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76308538	FDA UDI	Class I	Active
Headed Screw System	409-45356	FDA UDI	Class II	Active
Tyber Medical	Headless Ø3.0 x 39mm Full Thread Ti (Torx)	FDA UDI	Class II	Unknown
Tyber Medical	502-P281588-S	FDA UDI	Class II	Active
Snap-Off Screw System	410-30234	FDA UDI	Class II	Active
A.L.P.S. mvX™	880401040S	FDA UDI	Class II	Active
Tyber Medical	Headed Cannulated Screw Long Ø2.5mm x 34mm	FDA UDI	Class II	Unknown
A.L.P.S. mvX™	770709082	EUDAMEDFDA UDI	Class II	Active
LEOS Cannulated Screw System	76354052LG	FDA UDI	Class II	Active
Tyber Medical	Headed Cannulated Screw Long Ø6.5mm x 95mm	FDA UDI	Class II	Unknown
Tyber Medical	Headed Cannulated Screw Long Ø4.5mm x 36mm	FDA UDI	Class II	Unknown
Snap-Off Screw System	410-15424	FDA UDI	Class II	Active
Tyber Medical	002-C141152	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76335558FT	FDA UDI	Class II	Active
Tyber Medical	PLIF 26mm x 12mm x 15mm x 0 degree	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76344070SH	FDA UDI	Class II	Active
A.L.P.S. mvX™	770602090	EUDAMEDFDA UDI	Class II	Active
A.L.P.S. mvX™	770131014	EUDAMEDFDA UDI	Class II	Active
Tyber Medical	Headless Ø3.0 x 36mm Full Thread Ti (Torx)	FDA UDI	Class II	Unknown
A.L.P.S. mvX™	770241036	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76317046SH	FDA UDI	Class II	Active
Orion Ti PEEK Wedge System Instruments	HTR-04-804585	FDA UDI	Class I	Active
Tyber Medical	302-P2817010-S	FDA UDI	Class II	Active
Headless Screw System	401-20321	FDA UDI	Class II	Active
Tyber Medical	Headless Ø3.0 x 26mm Full Thread Ti (Torx)	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.

Date	Recall No.	Class	Status	Reason
Dec 19, 2025	Z-1131-2026	—	open, classified	The supplier manufactured anatomical left plates with an incorrect thread orientation.
Dec 19, 2025	Z-1132-2026	—	open, classified	The supplier manufactured anatomical left plates with an incorrect thread orientation.
Jan 21, 2025	Z-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, 2025	Z-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, 2025	Z-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, 2025	Z-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, 2025	Z-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, 2025	Z-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, 2025	Z-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, 2025	Z-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, 2025	Z-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, 2025	Z-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, 2025	Z-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, 2025	Z-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, 2025	Z-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, 2025	Z-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, 2025	Z-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, 2025	Z-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, 2025	Z-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, 2025	Z-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