# K033065: Synthes 2.0 MM Craniofacial Locking Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Oct 29, 2003 after 30 days
- Product code: MQN (External Mandibular Fixator And/Or Distractor)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes 2.0 mm Craniofacial Plates: named in the summary without a submission number
- (no number) Synthes 2.0 mm Mandible Locking Plates: named in the summary without a submission number

## Indications for use
Synthes 2.0mm Craniofacial Loclang Plates are indicated for selective trauma of the midface and craniofacial skleton; craniofacial surgeIy, reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Source page: https://510kreport.com/device/K033065
Methodology: https://510kreport.com/methodology