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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 9 of 208

Device	Model / Reference	Registries	Class	Status
Tyber Medical	Headed Cannulated Screw Short Ø2.5mm x 40mm	FDA UDI	Class II	Active
Cannulated Screw System +	04.354.890S	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76308872	FDA UDI	Class I	Active
LEOS Cannulated Screw System	76315554SH	FDA UDI	Class II	Active
A.L.P.S. mvX™	770400020	EUDAMEDFDA UDI	Class II	Active
Leos	7620-3540	FDA UDI	Class II	Active
Tyber Medical	Headless Ø2.0 x 12mm Full Thread Ti (Torx)	FDA UDI	Class II	Unknown
A.L.P.S. mvX™	770102020	FDA UDI	Class II	Active
Tyber Medical	502-T2610001-S	FDA UDI	Class II	Active
Volt™ Wrist Treatment System	02.426.741	FDA UDI	Class II	Active
Tyber Medical	302-P308210-S	FDA UDI	Class II	Active
Volt™ Wrist Treatment System	02.426.830	FDA UDI	Class II	Active
A.L.P.S. mvX™	770400050	EUDAMEDFDA UDI	Class II	Active
LEOS Cannulated Screw System	76347080SH	FDA UDI	Class II	Active
Tyber Medical	M2-P289410-S	FDA UDI	Class II	Active
Tyber Medical	302-P2614410-S	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76325544LG	FDA UDI	Class II	Active
Tyber Medical	502-P2412012-S	FDA UDI	Class II	Active
Tyber Medical	Headless Ø6.5 x 32mm Full Thread Ti (Torx)	FDA UDI	Class II	Active
Tyber Medical	Headed Cannulated Screw Short Ø2.5mm x 32mm	FDA UDI	Class II	Active
Tyber Medical	302-P2610012-S	FDA UDI	Class II	Active
Tyber Medical	502-P3212210-S	FDA UDI	Class II	Active
Tyber Medical	302-P2810012-S	FDA UDI	Class II	Active
Tyber Medical	Headless Ø4.5 x 21mm Short Thread Ti (Torx)	FDA UDI	Class II	Unknown
Tyber Medical	Headless Ø2.0 x 14mm Short Thread Ti (Torx)	FDA UDI	Class II	Unknown
Ti-Fix OLIF Spacer	P-321008-0	FDA UDI	Class II	Active
Tyber Medical	35-14120505	FDA UDI	Class II	Active
Tyber Medical	Headless Ø2.0 x 33mm Long Thread Ti (Torx)	FDA UDI	Class II	Unknown
Tyber Medical	302-P2410412-S	FDA UDI	Class II	Active
Tyber Medical	302-T269001-S	FDA UDI	Class II	Active
Sterile ACIF PEEK	810-140900	FDA UDI	Class II	Active
Tyber Medical	502-P229410-S	FDA UDI	Class II	Active
Tyber Medical	502-T2616001-S	FDA UDI	Class II	Active
Tyber Medical	002-C141255	FDA UDI	Class II	Active
Tyber Medical	502-P24788-S	FDA UDI	Class II	Active
Snap-Off Screw System Instruments	010-000001	FDA UDI	Class I	Active
Tyber Medical	302-P261748-S	FDA UDI	Class II	Active
Headed Screw System	9ZB25232	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB80370	FDA UDI	Class II	Active
A.L.P.S. mvX™	770200023	EUDAMEDFDA UDI	Class II	Active
Riptide	6ZBZC2507	FDA UDI	Class II	Active
Snap-Off Screw System	410-25318	FDA UDI	Class II	Active
Tyber Medical	302-P2212412-S	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB654120	FDA UDI	Class II	Active
Volt™ Wrist Treatment System	02.426.740	FDA UDI	Class II	Active
Tyber Medical	Headless Ø3.0 x 30mm Long Thread Ti (Torx)	FDA UDI	Class II	Unknown
Tyber Medical	502-P281108-S	FDA UDI	Class II	Active
CONCORDE® ProTi 360°™	188831210	FDA UDI	Class II	Active
Tyber Medical	Headless Ø1.5 x 28mm Short Thread Ti (Torx)	FDA UDI	Class II	Active
Cannulated Screw System +	04.353.648TS	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