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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 12 of 208

Device	Model / Reference	Registries	Class	Status
Tyber Medical	302-P281048-S	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB40338	FDA UDI	Class II	Active
ACIS® ProTi 360°™	108843405	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB65456	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB50458	FDA UDI	Class II	Active
Tyber Medical	502-P321328-S	FDA UDI	Class II	Active
CONCORDE® ProTi 360°™	188831209	FDA UDI	Class II	Active
Headless Screw System	401-30334	FDA UDI	Class II	Active
Snap-Off Screw System	410-15220	FDA UDI	Class II	Active
Tyber Medical	Headless Ø4.5 x 44mm Long Thread Ti (Torx)	FDA UDI	Class II	Active
Tyber Medical	Headless Ø4.5 x 80mm Short Thread Ti (Torx)	FDA UDI	Class II	Active
Tyber Medical	002-P321308	FDA UDI	Class II	Active
Tyber Medical	302-P261308-S	FDA UDI	Class II	Active
Fps	M25-605041	FDA UDI	Class II	Active
Tyber Medical	302-P3012012-S	FDA UDI	Class II	Active
Tyber Medical	Headless Ø4.5 x 90mm Short Thread Ti (Torx)	FDA UDI	Class II	Active
Tyber Medical	502-P301328-S	FDA UDI	Class II	Active
Tyber Medical	Headed Cannulated Screw Long Ø3.0mm x 16mm	FDA UDI	Class II	Unknown
Fps	M25-712252	FDA UDI	Class II	Active
A.L.P.S. mvX™	770800024	EUDAMEDFDA UDI	Class II	Active
A.L.P.S. mvX™	770350070	EUDAMEDFDA UDI	Class II	Active
A.L.P.S. mvX™	770101040	EUDAMEDFDA UDI	Class II	Active
LEOS Cannulated Screw System	76308558	FDA UDI	Class I	Active
Leos	7622-3231	FDA UDI	Class II	Active
CONCORDE® ProTi 360°™	188827413	FDA UDI	Class II	Active
Tyber Medical	302-T2811001-S	FDA UDI	Class II	Active
GEO Hammertoe	15012013	FDA UDI	Class II	Active
Tyber Medical	Headless Ø4.5 x 25mm Short Thread Ti (Torx)	FDA UDI	Class II	Unknown
ACIF Interbody System	M2-C16555-S	FDA UDI	Class II	Active
Tyber Medical	302-P3017012-S	FDA UDI	Class II	Active
Orion Headed Screw	HTR-04-404616	FDA UDI	Class II	Active
ACIS® ProTi 360™ HL	208843008	FDA UDI	Class II	Active
Interbody System Instruments	002-000099	FDA UDI	Class I	Active
Fps	M25-302024	FDA UDI	Class II	Active
A.L.P.S. mvX™	770201007	EUDAMEDFDA UDI	Class II	Active
LEOS Cannulated Screw System	76317052SH	FDA UDI	Class II	Active
Snap-Off Screw System	410-30419	FDA UDI	Class II	Active
Tyber Medical	502-P221248-S	FDA UDI	Class II	Active
Tyber Medical	502-P2815810-S	FDA UDI	Class II	Active
Orion Ti PEEK Wedge System Instruments	HTR-04-014905	FDA UDI	Class I	Active
Tyber Medical	302-P2613812-S	FDA UDI	Class II	Active
Interbody System Instruments	002-000093	FDA UDI	Class I	Active
CONCORDE® ProTi 360°™	188827209	FDA UDI	Class II	Active
TPLIF Interbody System	M2-P2610010-S	FDA UDI	Class II	Active
TPLIF Interbody System	M2-P267810-S	FDA UDI	Class II	Active
Fps	M25-303013	FDA UDI	Class II	Active
Fps	F25-020001	FDA UDI	Class I	Active
Orion Headed Screw	HTR-04-304916	FDA UDI	Class II	Active
Fps	M25-252012	FDA UDI	Class II	Active
Tyber Medical	302-P2617812-S	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