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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 5 of 208

Device	Model / Reference	Registries	Class	Status
Tyber Medical	Headless Ø4.5 x 55mm Short Thread Ti (Torx)	FDA UDI	Class II	Active
Tyber Medical	002-P261488	FDA UDI	Class II	Active
Tyber Medical	302-P261088-S	FDA UDI	Class II	Active
Ti-Fix OLIF Spacer	P-301010-0	FDA UDI	Class II	Active
Headless Screw System	401-15213	FDA UDI	Class II	Active
A.L.P.S. mvX™	770270040	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76355565LG	FDA UDI	Class II	Active
CONCORDE® ProTi 360°™	188823106	FDA UDI	Class II	Active
Headless Screw System	401-15311	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB40222	FDA UDI	Class II	Active
TiLink-T	21-30100508	FDA UDI	Class II	Active
Hermes PEEK Straight Cage	HRM-P289012	FDA UDI	Class II	Active
TPLIF Interbody System	M2-P249810-S	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76342016	FDA UDI	Class II	Active
Tyber Medical	502-P32928-S	FDA UDI	Class II	Active
Tyber Medical	302-P3214010-S	FDA UDI	Class II	Active
Fps	M25-352040	FDA UDI	Class II	Active
Toegrip® Classic	TGXL00	FDA UDI	Class II	Active
CONCORDE® ProTi 360°™	188823210	FDA UDI	Class II	Active
Snap-Off Screw System	410-25410	FDA UDI	Class II	Active
Tyber Medical	Headed Cannulated Screw Short Ø6.5mm x 115mm	FDA UDI	Class II	Active
Tyber Medical	502-P3015012-S	FDA UDI	Class II	Active
TPLIF Interbody System	M2-T2614523-S	FDA UDI	Class II	Active
Tyber Medical	502-P289810-S	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB65342	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB65246	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB80285	FDA UDI	Class II	Active
Fps	F25-002030	FDA UDI	Class I	Active
Tyber Medical	502-P2811010-S	FDA UDI	Class II	Active
A.L.P.S. mvX™	770201015	EUDAMEDFDA UDI	Class II	Active
Tyber Medical	PLIF 28mm x 12mm x 17mm x 0 °, PEEK, Sterile	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76342030	FDA UDI	Class II	Active
Leos	7624-4121	FDA UDI	Class I	Active
Leos	7620-3522	FDA UDI	Class II	Active
A.L.P.S. mvX™	770606060	FDA UDI	Class II	Active
Tyber Medical	502-P2610410-S	FDA UDI	Class II	Active
Tyber Medical	302-P307212-S	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76317082SH	FDA UDI	Class II	Active
A.L.P.S. mvX™	770350024	EUDAMEDFDA UDI	Class II	Active
Tyber Medical	Headed Cannulated Screw Long Ø6.5mm x 48mm	FDA UDI	Class II	Unknown
Tyber Medical	Headless Ø6.5 x 46mm Full Thread Ti (Torx)	FDA UDI	Class II	Active
Headless Screw System	401-20210	FDA UDI	Class II	Active
A.L.P.S. mvX™	770271032	EUDAMEDFDA UDI	Class II	Active
Fps	M25-402020	FDA UDI	Class II	Active
Leos	7621-3522	FDA UDI	Class II	Active
Tyber Medical	502-T2610523-S	FDA UDI	Class II	Active
A.L.P.S. mvX™	770200034	EUDAMEDFDA UDI	Class II	Active
Tyber Medical	302-P301108-S	FDA UDI	Class II	Active
Fps	M25-201020	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76343010	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