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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 2 of 208

Device	Model / Reference	Registries	Class	Status
Tyber Medical	Headed Cannulated Screw Long Ø4.5mm x 22mm	FDA UDI	Class II	Unknown
A.L.P.S. mvX™	770270034	EUDAMEDFDA UDI	Class II	Active
A.L.P.S. mvX™	880450060S	FDA UDI	Class II	Active
A.L.P.S. mvX™	770450070	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76344030SH	FDA UDI	Class II	Active
TyFix Hammertoe System	413-C20013-S	FDA UDI	Class II	Active
Tyber Medical	502-P2410812-S	FDA UDI	Class II	Active
Headless Screw System	401-20216	FDA UDI	Class II	Active
Tyber Medical	502-P289412-S	FDA UDI	Class II	Active
Tyber Medical	302-P221088-S	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76357044LG	FDA UDI	Class II	Active
Headed Screw System	409-45258	FDA UDI	Class II	Active
Leos	7621-2714	FDA UDI	Class II	Active
Tyber Medical	302-P249412-S	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB652135	FDA UDI	Class II	Active
Tyber Medical	Headless Ø1.5 x 24mm Full Thread Ti (Torx)	FDA UDI	Class II	Unknown
Snap-Off Screw System	410-20439	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB65395	FDA UDI	Class II	Active
Leos	7622-3121	FDA UDI	Class II	Active
A.L.P.S. mvX™	770502090	EUDAMEDFDA UDI	Class II	Active
Fps	F25-032001	FDA UDI	Class I	Active
A.L.P.S. mvX™	880352050S	FDA UDI	Class II	Active
Orion Headed Screw	HTR-04-304116	FDA UDI	Class II	Active
Tyber Medical	002-T3015002	FDA UDI	Class II	Active
Leos	7620-4032	FDA UDI	Class II	Active
Leos	7624-3022	FDA UDI	Class I	Active
Fps	M25-602030	FDA UDI	Class II	Active
Cannulated Screw System +	04.355.850TS	FDA UDI	Class II	Active
Ti-Fix OLIF Spacer	P-301208-0	FDA UDI	Class II	Active
Orion Headed Screw	HTR-04-204314	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB65350	FDA UDI	Class II	Active
Foot Osteotomy Wedge System	03.844.104	FDA UDI	Class I	Active
Orion Ti PEEK Wedge System Instruments	HTR-04-004002	FDA UDI	Class I	Active
LEOS Cannulated Screw System	76337070FT	FDA UDI	Class II	Active
Fps	M25-304038	FDA UDI	Class II	Active
Snap-Off Screw System	410-20332	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB65332	FDA UDI	Class II	Active
Leos	7621-4016	FDA UDI	Class II	Active
Tyber Medical	302-P2412410-S	FDA UDI	Class II	Active
ACIS® ProTi 360™ HL	208843312	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76309530	FDA UDI	Class I	Active
FuseFix Hammertoe	M13-S30015-S	FDA UDI	Class II	Active
A.L.P.S. mvX™	770400080	EUDAMEDFDA UDI	Class II	Active
A.L.P.S. mvX™	770271095	FDA UDI	Class II	Active
Steriflex Ht	RAHT-2X15C	FDA UDI	Class II	Active
Cannulated Screw System +	04.353.548	FDA UDI	Class II	Active
Orion Headed Screw	HTR-04-404940	FDA UDI	Class II	Active
Snap-off Screw System	401-25334-S	FDA UDI	Class II	Unknown
Tyber Medical	Headless Ø1.5 x 10mm Short Thread Ti (Torx)	FDA UDI	Class II	Unknown
Tyber Medical	Headless Ø3.0 x 18mm Long Thread Ti (Torx)	FDA UDI	Class II	Unknown

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