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QZZClass II

Limb And Joint Salvage Device With Coating For Bacteria Reduction

21 CFR 888.3900 / Orthopedic
FDA source (opens on fda.gov)

QZZ is the FDA product code for Limb And Joint Salvage Device With Coating For Bacteria Reduction, a class II device type, regulated under 21 CFR 888.3900. FDA's definition for this code reads: "A limb and joint salvage device with quaternary ammonium compound coating is a metallic implant with or without polymer bearing for bone and joint replacement. Implants are for resection and replacement of an extremity bone (including the entire bone, epiphyseal bone, metaphyseal bone, or diaphyseal bone), or an...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QZZ
Device name
Limb And Joint Salvage Device With Coating For Bacteria Reduction
FDA definition
A limb and joint salvage device with quaternary ammonium compound coating is a metallic implant with or without polymer bearing for bone and joint replacement. Implants are for resection and replacement of an extremity bone (including the entire bone, epiphyseal bone, metaphyseal bone, or diaphyseal bone), or an extremity bone and the surrounding joint(s) in a skeletally mature patient. The device includes a quaternary ammonium compound coating that is covalently bonded to the device. Where applied, the coating is intended to reduce microbial contamination on the surface of the device prior to implantation. The device does not contain antimicrobial agents that act within or on the body and this device type does not include combination products.
Regulation
21 CFR 888.3900
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code QZZ

By decision year
3 clearances under product code QZZ with a decision year between 2024 and 2026, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QZZ by decision year
YearClearances
20241
20251
20261

Applicants with the most clearances

Product code QZZ
Applicants holding the most 510(k) clearances under product code QZZ
ApplicantClearances
Onkos Surgical, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code