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In2Bones, USA

United States·US-MF-000023092

Last updated September 17, 2026

Information

Country: United States
Address: 7750a, Trinity Road, Cordova, United States
Website: www.conmed.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +18664266633
PRRC Contact: Brent Lalomia
EUDAMED SRN: US-MF-000023092
FDA FEI Number: 3011580264
DUNS Number: —

Catalogue (1746)

Page 32 of 35

Device	Model / Reference	Registries	Class	Status
5ms™	P60 ST747	FDA UDI	Class II	Active
CoLag 2	P67 ST232	FDA UDI	Class II	Active
CoLink™ Afx	P73 ST145	FDA UDI	Class II	Active
Fracture and Correction CoLag™ 2	P67 ST875	FDA UDI	Class II	Active
5ms™	P60 ST452	FDA UDI	Class II	Active
5ms™	P60 ST650	FDA UDI	Class II	Active
SubChon	C01 S1001	FDA UDI	Class I	Active
CoLink™ Afx	P73 ST142	FDA UDI	Class II	Active
Fracture and Correction CoLag™ 2	P67 ST895	FDA UDI	Class II	Active
Fracture and Correction CoLag™ 2	P67 ST860	FDA UDI	Class II	Active
CoLag™	P65 ST842	FDA UDI	Class II	Active
CoLag™	P65 ST324	FDA UDI	Class II	Unknown
CoLag 2	P67 ST447	FDA UDI	Class II	Active
CoLag 2	P67 ST428	FDA UDI	Class II	Active
CoLag™	P65 ST838	FDA UDI	Class II	Active
CoLink™ Afx	P74 ST012	FDA UDI	Class II	Active
CoLag™	P65 ST882	FDA UDI	Class II	Active
5ms™	P62 ST715	FDA UDI	Class II	Active
Fracture and Correction CoLag™ 2	P67 ST657	FDA UDI	Class II	Active
5ms™	P62 ST710	FDA UDI	Class II	Active
CoLag 2	P67 ST111	FDA UDI	Class II	Active
5ms™	P60 ST642	FDA UDI	Class II	Active
5ms™	P62 ST426	FDA UDI	Class II	Active
Fracture and Correction CoLag™ 2	P68 ST250	FDA UDI	Class II	Active
CoLag 2	P67 ST230	FDA UDI	Class II	Active
5ms™	P62 ST418	FDA UDI	Class II	Active
CoLink™	V35 ST338	EUDAMEDFDA UDI	Class IIb	Active
CoLink™	V35 ST224	EUDAMEDFDA UDI	Class IIb	Active
5ms	P06 N0661	EUDAMEDFDA UDI	Class I	Active
CoLink™	V30 ST428	EUDAMEDFDA UDI	Class IIb	Active
CoLink™	V30 ST212	EUDAMEDFDA UDI	Class IIb	Active
5ms	P06 N0441	EUDAMEDFDA UDI	Class I	Active
5ms	P06 N0411	EUDAMEDFDA UDI	Class I	Active
CoLink™	V35 ST238	EUDAMEDFDA UDI	Class IIb	Active
CoLink Sfx Implant System	K203698	FDA 510(k)	Class II	Active
CoLink Cfx Plating System	K200762	FDA 510(k)	Class II	Active
Avenger Radial Head System	K212872	FDA 510(k)	Class II	Active
CoLink View Plating System	K182402	FDA 510(k)	Class II	Active
CoLink View Plating System	K172300	FDA 510(k)	Class II	Active
Avenger Radial Head System	K192754	FDA 510(k)	Class II	Active
RTS Flexible 1 MPJ Implant w/Grommets	K153609	FDA 510(k)	Class II	Active
CoLink Mfx Implant System	K210060	FDA 510(k)	Class II	Active
NeoSpan Compression Staple Impant w/instruments	K161426	FDA 510(k)	Class II	Active
CoLink NeoFuse Plating System	K213069	FDA 510(k)	Class II	Active
CoLink NeoFuse MIS Plating System (see attached parts list)	K241387	FDA 510(k)	Class II	Active
Hercules Suture Anchor System	K201636	FDA 510(k)	Class II	Active
Hercules Syndesmosis Implant System	K220260	FDA 510(k)	Class II	Active
CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System	K193543	FDA 510(k)	Class II	Active
RTS Lesser MTP Implant System	K173491	FDA 510(k)	Class II	Active
NeoSpan® Compression Implant System	K233089	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

Conmed Europe BV BE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (2)

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
Aug 18, 2021	Z-2506-2021	—	terminated	Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
Nov 14, 2018	Z-0670-2019	—	terminated	The NeoSpan Compression Staple (10x10x10) kits from two lots contain the wrong size drill bit. They contain a 3mm drill bit instead of a 2mm drill bit.