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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 10 of 208

Device	Model / Reference	Registries	Class	Status
LEOS Cannulated Screw System	76357095LG	FDA UDI	Class II	Active
Snap-Off Screw System	410-30327	FDA UDI	Class II	Active
Tyber Medical	Headed Cannulated Screw Long Ø2.5mm x 27mm	FDA UDI	Class II	Unknown
LEOS Cannulated Screw System	76343524	FDA UDI	Class II	Active
Leos	7621-4018	FDA UDI	Class II	Active
Toegrip® Classic	TGMM10	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB654100	FDA UDI	Class II	Active
Snap-Off Screw System	410-30426	FDA UDI	Class II	Active
Leos	7624-4120	FDA UDI	Class I	Active
Orion Headed Screw	HTR-04-404655	FDA UDI	Class II	Active
Tyber Medical	302-T289501-S	FDA UDI	Class II	Active
Ti-Fix OLIF Spacer	002-P3014010	FDA UDI	Class II	Active
Fps	M25-301011	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB40265	FDA UDI	Class II	Active
Tyber Medical	502-P32808-S	FDA UDI	Class II	Active
Tyber Medical	ACP Level 2, 30 mm	FDA UDI	Class II	Active
Snap-Off Screw System	410-30423	FDA UDI	Class II	Active
Tyber Medical	Headless Ø3.0 x 36mm Short Thread Ti (Torx)	FDA UDI	Class II	Unknown
Tyber Medical	302-P2617412-S	FDA UDI	Class II	Active
Tyber Medical	502-P2815412-S	FDA UDI	Class II	Active
Tyber Medical	Headless Ø4.5 x 32mm Long Thread Ti (Torx)	FDA UDI	Class II	Active
Tyber Medical	002-T2812004	FDA UDI	Class II	Active
TPLIF Interbody System	M2-P3213010-S	FDA UDI	Class II	Active
Orion Headed Screw	HTR-04-454420	FDA UDI	Class II	Active
Tyber Medical	Headless Ø4.5 x 28mm Full Thread Ti (Torx)	FDA UDI	Class II	Unknown
Tyber Medical	302-P2212012-S	FDA UDI	Class II	Active
Unitus	15ZB00106	FDA UDI	Class II	Active
Volt™ Wrist Treatment System	02.426.541	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76357115LG	FDA UDI	Class II	Active
Tyber Medical	502-P248012-S	FDA UDI	Class II	Active
Tyber Medical	502-P228410-S	FDA UDI	Class II	Active
TPLIF Interbody System	M2-P3214010-S	FDA UDI	Class II	Active
Tyber Medical	302-T2810001-S	FDA UDI	Class II	Active
Tyber Medical	302-P28808-S	FDA UDI	Class II	Active
Tyber Medical	302-P301728-S	FDA UDI	Class II	Active
ACIS® ProTi 360°™	108843309	FDA UDI	Class II	Active
Tyber Medical	502-P228010-S	FDA UDI	Class II	Active
Snap-Off Screw System	410-20425	FDA UDI	Class II	Active
Headless Screw System	401-30235	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76308510	FDA UDI	Class I	Active
Tyber Medical	302-P221348-S	FDA UDI	Class II	Active
Fps	M25-732031	FDA UDI	Class II	Active
Fps	M25-352060	FDA UDI	Class II	Active
TPLIF Interbody System	002-001121	FDA UDI	Class I	Active
Tyber Medical	Headless Ø3.0 x 29mm Short Thread Ti (Torx)	FDA UDI	Class II	Active
Tyber Medical	Headless Ø1.5 x 8mm Long Thread Ti (Torx)	FDA UDI	Class II	Unknown
Cannulated Compression Headless Screw	1ZB40275	FDA UDI	Class II	Active
TPLIF Interbody System	002-001128	FDA UDI	Class I	Active
A.L.P.S. mvX™	770800020	EUDAMEDFDA UDI	Class II	Active
Snap-Off Screw System	410-25224	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