MANZA POLYETHYLENE LINER 102-10-033

GUDID 00841176101128

MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 32 E

STINSON ORTHOPEDICS INC.

Non-constrained polyethylene acetabular liner
Primary Device ID00841176101128
NIH Device Record Key634dbea7-c4c0-41ea-a5ef-f15ba562bd00
Commercial Distribution StatusIn Commercial Distribution
Brand NameMANZA POLYETHYLENE LINER
Version Model Number102-10-033
Catalog Number102-10-033
Company DUNS080460688
Company NameSTINSON ORTHOPEDICS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
GS100841176101128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-26

On-Brand Devices [MANZA POLYETHYLENE LINER]

00841176101333MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 40 E 10 DEGREE
00841176101326MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 40 E
00841176101319MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 40 D
00841176101159MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 36 E
00841176101142MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 36 D
00841176101135MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 36 C
00841176101128MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 32 E
00841176101111MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 32 D
00841176101104MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 32 C
00841176101098MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 32 B
00841176101081MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 28 C
00841176101074MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 28 B
00841176101067MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 28 A
00841176101043MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 40 E
00841176101036MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 40 D
00841176101029MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 36 E
00841176101012MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 36 D
00841176101005MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 36 C
00841176100992MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 32 E
00841176100985MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 32 D
00841176100978MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 32 C
00841176100961MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 32 B
00841176100954MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 28 C
00841176100947MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 28 B
00841176100930MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 28 A
00841176100916MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 40 D 10 DEGREE
00841176100909MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 36 E 10 DEGREE
00841176100893MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 36 D 10 DEGREE
00841176100886MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 32 E 10 DEGREE
00841176100879MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 32 D 10 DEGREE
00841176100862MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 32 C 10 DEGREE
00841176100855MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 32 B 10 DEGREE
00841176100848MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 28 C 10 DEGREE
00841176100831MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 28 B 10 DEGREE
00841176100824MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 28 A 10 DEGREE
00841176100817MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 40 E
00841176100800MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 40 D
00841176100794MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 36 E
00841176100787MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 36 D
00841176100770MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 36 C
00841176100763MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 32 E
00841176100756MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 32 D
00841176100749MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 32 C
00841176100732MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 32 B
00841176100725MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 28 C
00841176100718MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 28 B
00841176100701MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 28 A
00841176100695MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 36 C 10 DEGREE

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