Large Compression Screws— 510(k) K262344
Substantially EquivalentTriMed, Inc.
FDA 510(k) clearance K262344 for Large Compression Screws, Substantially Equivalent on 2026-08-12. Applicant: TriMed, Inc.. Device class: 2.
Summary
TriMed's Large Compression Screws are filed under product code HWC, bone fixation screws. The device name is generic, and the record gives no sizes or model numbers.
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).
TriMed filed from Santa Clarita, California. The decision came 33 calendar days after receipt (July 10 to August 12, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- TriMed, Inc.
- 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
- Santa Clarita, CA, US
Recent devices under product code HWC
view allMore clearances from TriMed, Inc.
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.