CoLink® & CoLag® Non-Sterile Screws— 510(k) K261154
Substantially EquivalentIn2Bones USA, LLC
FDA 510(k) clearance K261154 for CoLink® & CoLag® Non-Sterile Screws, Substantially Equivalent on 2026-05-30. Applicant: In2Bones USA, LLC. Device class: 2.
Summary
In2Bones USA's CoLink and CoLag Non-Sterile Screws are filed under HWC, bone fixation screws.
Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel, and it came in as a Special 510(k).
In2Bones filed from Cordova, Tennessee. The decision came 52 calendar days after receipt (April 8 to May 30, 2026), and FDA found it substantially equivalent.
Clearance details
- Applicant
- In2Bones USA, LLC
- Product code
- Product code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Cordova, TN, US
Recent devices under product code HWC
view allMore clearances from In2Bones USA, LLC
view allAdverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.