FREEDOM PRIMARY PCK

GUDID 00811767025645

FEMORAL PRIMARY PCK F, LEFT

MAXX ORTHOPEDICS, INC.

Uncoated knee femur prosthesis, metallic
Primary Device ID00811767025645
NIH Device Record Key4564d426-71e4-4beb-b70e-aaa700b192f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameFREEDOM PRIMARY PCK
Version Model NumberLFPSLF00-ML
Company DUNS792030103
Company NameMAXX ORTHOPEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100811767025645 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2017-02-28

On-Brand Devices [FREEDOM PRIMARY PCK]

00811767025713FEMORAL PRIMARY PCK A, RIGHT
00811767025706FEMORAL PRIMARY PCK A, LEFT
00811767025690FEMORAL PRIMARY PCK H, RIGHT
00811767025683FEMORAL PRIMARY PCK H, LEFT
00811767025676FEMORAL PRIMARY PCK G, RIGHT
00811767025669FEMORAL PRIMARY PCK G, LEFT
00811767025652FEMORAL PRIMARY PCK F, RIGHT
00811767025645FEMORAL PRIMARY PCK F, LEFT
00811767025638FEMORAL PRIMARY PCK E, RIGHT
00811767025621FEMORAL PRIMARY PCK E, LEFT
00811767025614FEMORAL PRIMARY PCK D, RIGHT
00811767025607FEMORAL PRIMARY PCK D, LEFT
00811767025591FEMORAL PRIMARY PCK C, RIGHT
00811767025584FEMORAL PRIMARY PCK C, LEFT
00811767025577FEMORAL PRIMARY PCK B, RIGHT
00811767025560FEMORAL PRIMARY PCK B, LEFT

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.