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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 6 of 208

Device	Model / Reference	Registries	Class	Status
Orion Headed Screw	HTR-04-454285	FDA UDI	Class II	Active
Fps	M25-303032	FDA UDI	Class II	Active
ACIF Interbody System	M2-C14855-S	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB80490	FDA UDI	Class II	Active
Tyber Medical	002-T2810004	FDA UDI	Class II	Active
Orion Headed Screw	HTR-04-454750	FDA UDI	Class II	Active
Orion Headed Screw	HTR-04-654530	FDA UDI	Class II	Active
A.L.P.S. mvX™	770607120	EUDAMEDFDA UDI	Class II	Active
A.L.P.S. mvX™	770150018	EUDAMEDFDA UDI	Class II	Active
LEOS Cannulated Screw System	76312030	FDA UDI	Class II	Active
Tyber Medical	502-P2210812-S	FDA UDI	Class II	Active
Tyber Medical	Headed Cannulated Screw Short Ø2.5mm x 15mm	FDA UDI	Class II	Active
Fps	F25-018011	FDA UDI	Class I	Active
Fps	M25-252026	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76354048LG	FDA UDI	Class II	Active
Tyber Medical	502-P2811810-S	FDA UDI	Class II	Active
Volt™ Wrist Treatment System	02.426.730	FDA UDI	Class II	Active
Tyber Medical	302-P2211410-S	FDA UDI	Class II	Active
Snap-Off Screw System	410-15320	FDA UDI	Class II	Active
TPLIF Interbody System	M2-P2615810-S	FDA UDI	Class II	Active
A.L.P.S. mvX™	770241024	FDA UDI	Class II	Active
Tyber Medical	Headless Ø2.0 x 28mm Short Thread Ti (Torx)	FDA UDI	Class II	Active
Wedge System Instruments	006-000003	FDA UDI	Class I	Active
Headless Screw System	401-30217	FDA UDI	Class II	Active
Tyber Medical	502-P2814010-S	FDA UDI	Class II	Active
CONCORDE® ProTi 360°™	188827114	FDA UDI	Class II	Active
Fps	M25-714001	FDA UDI	Class II	Active
Fps	M25-733012	FDA UDI	Class II	Active
Tyber Medical	502-P2813812-S	FDA UDI	Class II	Active
A.L.P.S. mvX™	770200022	EUDAMEDFDA UDI	Class II	Active
Tyber Medical	002-P26708	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB654130	FDA UDI	Class II	Active
Tyber Medical	502-T2616523-S	FDA UDI	Class II	Active
Headless Screw System	401-30216	FDA UDI	Class II	Active
Tyber Medical	002-000069	FDA UDI	Class II	Active
Tyber Medical	Headless Ø1.5 x 16mm Long Thread Ti (Torx)	FDA UDI	Class II	Active
Snap-off Screw System	401-25330-S	FDA UDI	Class II	Unknown
Headless Screw System	401-20331	FDA UDI	Class II	Active
ACIS® ProTi 360°™	108843612	FDA UDI	Class II	Active
Tyber Medical	302-P269012-S	FDA UDI	Class II	Active
Tyber Medical	302-P249410-S	FDA UDI	Class II	Active
Toegrip® Evo	TGEXS00	FDA UDI	Class II	Active
Tyber Medical	Headless Ø3.0 x 27mm Short Thread Ti (Torx)	FDA UDI	Class II	Unknown
Tyber Medical	Headless Ø2.0 x 26mm Full Thread Ti (Torx)	FDA UDI	Class II	Unknown
Tyber Medical	502-P221088-S	FDA UDI	Class II	Active
Tyber Medical	502-P24948-S	FDA UDI	Class II	Active
A.L.P.S mvX™	770104030	EUDAMEDFDA UDI	Class II	Active
Tyber Medical	ACP Level 1, 24 mm	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB50222	FDA UDI	Class II	Active
Hermes PEEK Straight Cage	HRM-P2411010	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