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HXN – Applier, Cerclage
Applier, Cerclage
FDA product code
HXN
· Class I (low risk) · 21 CFR 888.4540 ·
Orthopedic
2
510(k) clearances
0
PMA approvals
0
recalls
Manufacturers
Plastafil, Inc.
1
Biomet, Inc.
1
510(k) clearances
510(k)
Device
Applicant
Decision
K024022
Osteo-Cable Sleeve
HXN · Special
Biomet, Inc.
01/23/2003
SE
K841628
Wire
HXN · Traditional
Plastafil, Inc.
07/23/1984
SE