ENCINA HA FEMORAL STEM STANDARD OFFSET 100-00-013

GUDID 00841176100077

ENCINA HA FEMORAL STEM STANDARD OFFSET, SZ 13

STINSON ORTHOPEDICS INC.

Coated femoral stem prosthesis, modular
Primary Device ID00841176100077
NIH Device Record Key7b1f0e5f-6b9a-43e8-b602-e8d6397cc96b
Commercial Distribution StatusIn Commercial Distribution
Brand NameENCINA HA FEMORAL STEM STANDARD OFFSET
Version Model Number100-00-013
Catalog Number100-00-013
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
GS100841176100077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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 [ENCINA HA FEMORAL STEM STANDARD OFFSET]

00841176100114ENCINA HA FEMORAL STEM STANDARD OFFSET, SZ 18
00841176100107ENCINA HA FEMORAL STEM STANDARD OFFSET, SZ 16
00841176100091ENCINA HA FEMORAL STEM STANDARD OFFSET, SZ 15
00841176100084ENCINA HA FEMORAL STEM STANDARD OFFSET, SZ 14
00841176100077ENCINA HA FEMORAL STEM STANDARD OFFSET, SZ 13
00841176100060ENCINA HA FEMORAL STEM STANDARD OFFSET, SZ 12
00841176100053ENCINA HA FEMORAL STEM STANDARD OFFSET, SZ 11
00841176100046ENCINA HA FEMORAL STEM STANDARD OFFSET, SZ 10
00841176100039ENCINA HA FEMORAL STEM STANDARD OFFSET, SZ 9
00841176100022ENCINA HA FEMORAL STEM STANDARD OFFSET, SZ 8

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