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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 33 of 35

Device	Model / Reference	Registries	Class	Status
CoLink PCR Plating System	K213698	FDA 510(k)	Class II	Active
CoLink Plating System	K201149	FDA 510(k)	Class II	Active
Fracture and Correction System	K180377	FDA 510(k)	Class II	Active
Colink™ Plating System	K163293	FDA 510(k)	Class II	Active
CoLink Vallux Plating System	K212487	FDA 510(k)	Class II	Active
CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System	K190385	FDA 510(k)	Class II	Active
In2Bones Fracture and Correction System	K170518	FDA 510(k)	Class II	Active
CoLink® Mini Plating System	K191535	FDA 510(k)	Class II	Active
CoLink™ Afx Plating System	K181113	FDA 510(k)	Class II	Active
IBS-B MIS Beveled Screw System	K231236	FDA 510(k)	Class II	Active
CoLink™	V30 ST426	EUDAMEDFDA UDI	Class IIb	Active
In2Bones	P06 N0611	EUDAMEDFDA UDI	Class I	Active
CoLink	C02 S0001	EUDAMEDFDA UDI	Class IIa	Active
CoLink®	P40 ST255	EUDAMEDFDA UDI	Class IIb	Active
5ms	P06 N0471	EUDAMEDFDA UDI	Class I	Active
5ms	P06 N0521	EUDAMEDFDA UDI	Class I	Active
In2Bones	P02 S0161	EUDAMEDFDA UDI	Class IIa	Active
CoLink™	V35 ST214	EUDAMEDFDA UDI	Class IIb	Active
CoLink	P04 N0342	EUDAMEDFDA UDI	Class IIa	Active
CoLink™	V30 ST216	EUDAMEDFDA UDI	Class IIb	Active
In2Bones	P07 S0041	EUDAMEDFDA UDI	Class IIa	Active
CoLink Afx	P07 N1206	EUDAMEDFDA UDI	Class IIa	Active
In2Bones	P04 N0063	EUDAMEDFDA UDI	Class I	Active
In2Bones	P06 S2341	EUDAMEDFDA UDI	Class IIa	Active
CoLink®	P40 ST265	EUDAMEDFDA UDI	Class IIb	Active
5ms	P06 N0131	EUDAMEDFDA UDI	Class I	Active
Ibs-B	G01 N0221	EUDAMEDFDA UDI	Class I	Active
In2Bones	P06 S0681	EUDAMEDFDA UDI	Class IIa	Active
In2Bones	P04 N0022	EUDAMEDFDA UDI	Class I	Active
Ibs-B	G01 N0102	EUDAMEDFDA UDI	Class I	Active
In2Bones	G01 S0062	EUDAMEDFDA UDI	Class IIa	Active
5ms	P06 N0011	EUDAMEDFDA UDI	Class I	Active
Ibs-B	G01 404A00	EUDAMEDFDA UDI	Class I	Active
CoLink Afx	P07 N1111	EUDAMEDFDA UDI	Class IIa	Active
In2Bones	P06 S0411	EUDAMEDFDA UDI	Class IIa	Active
CoLink	P04 N0341	EUDAMEDFDA UDI	Class IIa	Active
In2Bones	P07 S0131	EUDAMEDFDA UDI	Class IIa	Active
Ibs-B	G01 405A01	EUDAMED	Class I	Active
5ms	P06 N0581	EUDAMEDFDA UDI	Class I	Active
CoLink®	P40 ST016	EUDAMEDFDA UDI	Class IIb	Active
CoLink Afx	P07 N1113	EUDAMEDFDA UDI	Class IIa	Active
Ibs	C01 S2001	EUDAMEDFDA UDI	Class IIa	Active
In2Bones	C01 S2431	EUDAMEDFDA UDI	Class IIa	Active
5ms	P06 210A00	EUDAMED	Class I	Active
CoLink Afx	P07 N1114	EUDAMEDFDA UDI	Class IIa	Active
CoLink Afx	P07 N1309	EUDAMEDFDA UDI	Class IIa	Active
In2Bones	P04 N0041	EUDAMEDFDA UDI	Class I	Active
CoLink™	V30 ST226	EUDAMEDFDA UDI	Class IIb	Active
CoLink Afx	P07 N1104	EUDAMEDFDA UDI	Class IIa	Active
In2Bones	P06 S0471	EUDAMEDFDA UDI	Class IIa	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.