FREEDOM PCK

GUDID 00811767023771

Tibial Liner PCK, Size E5-6

MAXX ORTHOPEDICS, INC.

Uncoated knee tibia prosthesis, polyethylene
Primary Device ID00811767023771
NIH Device Record Key67338eea-94c9-40b2-9144-528b11f0e89e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFREEDOM PCK
Version Model NumberRLPSXE517-RK
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 Dimensions

Depth17 Millimeter
Depth17 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100811767023771 [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 Date2015-10-12

On-Brand Devices [FREEDOM PCK]

00811767024310Stemmed Tibial Base Plate Size 8
00811767024303Stemmed Tibial Base Plate Size 7
00811767024297Stemmed Tibial Base Plate Size 6
00811767024280Stemmed Tibial Base Plate Size 5
00811767024273Stemmed Tibial Base Plate Size 4
00811767024266Stemmed Tibial Base Plate Size 3
00811767024259Stemmed Tibial Base Plate Size 2
00811767024242Stemmed Tibial Base Plate Size 1
00811767024235Tibial Liner PCK, Size H7-8
00811767024228Tibial Liner PCK, Size H7-8
00811767024211Tibial Liner PCK, Size H7-8
00811767024204Tibial Liner PCK, Size H7-8
00811767024198Tibial Liner PCK, Size H7-8
00811767024181Tibial Liner PCK, Size H7-8
00811767024174Tibial Liner PCK, Size H7-8
00811767024167Tibial Liner PCK, Size G7-8
00811767024150Tibial Liner PCK, Size G7-8
00811767024143Tibial Liner PCK, Size G7-8
00811767024136Tibial Liner PCK, Size G7-8
00811767024129Tibial Liner PCK, Size G7-8
00811767024112Tibial Liner PCK, Size G7-8
00811767024105Tibial Liner PCK, Size G7-8
00811767024099Tibial Liner PCK, Size G5-6
00811767024082Tibial Liner PCK, Size G5-6
00811767024075Tibial Liner PCK, Size G5-6
00811767024068Tibial Liner PCK, Size G5-6
00811767024051Tibial Liner PCK, Size G5-6
00811767024044Tibial Liner PCK, Size G5-6
00811767024037Tibial Liner PCK, Size G5-6
00811767024020Tibial Liner PCK, Size F7-8
00811767024013Tibial Liner PCK, Size F7-8
00811767024006Tibial Liner PCK, Size F7-8
00811767023993Tibial Liner PCK, Size F7-8
00811767023986Tibial Liner PCK, Size F7-8
00811767023979Tibial Liner PCK, Size F7-8
00811767023962Tibial Liner PCK, Size F7-8
00811767023955Tibial Liner PCK, Size F5-6
00811767023948Tibial Liner PCK, Size F5-6
00811767023931Tibial Liner PCK, Size F5-6
00811767023924Tibial Liner PCK, Size F5-6
00811767023917Tibial Liner PCK, Size F5-6
00811767023900Tibial Liner PCK, Size F5-6
00811767023894Tibial Liner PCK, Size F5-6
00811767023887Tibial Liner PCK, Size F3-4
00811767023870Tibial Liner PCK, Size F3-4
00811767023863Tibial Liner PCK, Size F3-4
00811767023856Tibial Liner PCK, Size F3-4
00811767023849Tibial Liner PCK, Size F3-4
00811767023832Tibial Liner PCK, Size F3-4
00811767023825Tibial Liner PCK, Size F3-4

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