Synthes 2.0 Mm Locking Plate System (2.0 LPS)
by Synthes (Usa) 510(k)
Active
510(k) K974555
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK974555 | Date3 Mar 1998 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JEY
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.4760
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Synthes 2.0 Mm Locking Plate System (2.0 LPS) is a bone fixation implant system designed for oral and maxillofacial surgery. It provides rigid fixation of skeletal segments using a series of plates and self‑drilling locking screws.
The system includes straight, crescent, atrophic, reconstruction, and specialty Y‑ or L‑plates, and is supplied with 1.5 mm or 2.0 mm locking screws. It is classified as a Class 2 dental device (product code JEY) and received FDA 510(k) clearance (K974555) via the traditional pathway.