In2Bones, USA
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000023092 FEI 3011580264
- Devices
- 1,933
- Registrations
- EUDAMEDFDA
- FDA recalls
- 62 ongoing
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- Conmed Europe BVBE
What In2Bones, USA makes
In2Bones manufactures orthopaedic hardware including non-sliding bone screws (e.g., CoLink® and CoLag™), non-bioabsorbable fixation plates, and reusable surgical tools like drill guides, implant templates, and trial-implant holders. Their portfolio also includes an elbow radius prosthesis and orthopaedic burs for surgical procedures. General internal orthopaedic fixation system implantation kits are part of their product line.
The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II categories. Products are listed via 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system. In2Bones operates from the United States.
Catalogue
Search and filter all 1,933 devicesShowing 1-50 of 1,933
Company details
- EUDAMED SRN
- US-MF-000023092
- FDA FEI number
- 3011580264
- EUDAMED status
- Active
- EUDAMED registered name
- In2Bones, USA
- Registered address
- 7750a, Trinity Road, 38018, Cordova, United States
- Website
- www.conmed.com
- Phone
- +18664266633
- PRRC contact
- Brent Lalomia
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 6 Sep 2028
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 750773 Active
Quality management system EU MDR
- Issued
- 10 Nov 2025
- Expires
- 6 Sep 2028
- Reason
- Add device or group
FDA recalls
FDA recall records list 6 recalls initiated by In2Bones, USA, the earliest on 2018-07-16 and the most recent on 2026-09-09. By recorded status: 2 ongoing and 4 terminated. The reasons filed fall into these groups: labeling or instructions for use and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 3
- 2019 0
- 2020 0
- 2021 1
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 2
2026
- 9 Sep 2026 Z-0157-2027 Class II Ongoing Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
- 11 May 2026 Z-2355-2026 Class II Ongoing Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
Full distribution text
2021
- 18 Aug 2021 Z-2506-2021 Class II Terminated Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
Full distribution text
- 18 Aug 2021 Z-2506-2021 Class II Terminated Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
2018
- 14 Nov 2018 Z-0670-2019 Class II 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.
- 16 Jul 2018 Z-2879-2018 Class II Terminated CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates.
- 16 Jul 2018 Z-2880-2018 Class II Terminated CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates.
Frequently asked questions
How many devices does In2Bones, USA have in the registry?
The registry currently lists 1933 devices for In2Bones, USA. Devices recorded under merged duplicate company entries are counted once.
Which registries list In2Bones, USA's devices?
Among its 50 most recently registered devices, In2Bones, USA has devices listed in FDA GUDID (50 devices).
What risk classes do In2Bones, USA's devices fall under?
Among its 50 most recently registered devices, the classes recorded for In2Bones, USA's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for In2Bones, USA?
FDA recall records list 6 recalls initiated by In2Bones, USA, the most recent initiated on 9 Sep 2026. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for In2Bones, USA?
EUDAMED lists 1 certificate for In2Bones, USA (quality management system) under MDR. The most recent was issued on 10 Nov 2025.
What are the newest devices from In2Bones, USA in the registry?
The most recently registered devices listed for In2Bones, USA include Hercules A40 SPB01, IBS-B MIS S34 ST716, IBS-B MIS S34 ST718 and IBS-B MIS S34 ST720.