ENCINA TAPER FEMORAL STEM STANDARD OFFSET 110-00-006

GUDID 00841176100381

ENCINA TAPER STEM STANDARD OFFSET, SZ 6

STINSON ORTHOPEDICS INC.

Coated hip femur prosthesis, modular
Primary Device ID00841176100381
NIH Device Record Key1a4ebe13-701b-4d22-8011-216442e2fabb
Commercial Distribution StatusIn Commercial Distribution
Brand NameENCINA TAPER FEMORAL STEM STANDARD OFFSET
Version Model Number110-00-006
Catalog Number110-00-006
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
GS100841176100381 [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 TAPER FEMORAL STEM STANDARD OFFSET]

00841176101524ENCINA TAPER STEM STANDARD OFFSET, SZ 12
00841176101517ENCINA TAPER STEM STANDARD OFFSET, SZ 11
00841176100428ENCINA TAPER STEM STANDARD OFFSET, SZ 10
00841176100411ENCINA TAPER STEM STANDARD OFFSET, SZ 9
00841176100404ENCINA TAPER STEM STANDARD OFFSET, SZ 8
00841176100398ENCINA TAPER STEM STANDARD OFFSET, SZ 7
00841176100381ENCINA TAPER STEM STANDARD OFFSET, SZ 6
00841176100374ENCINA TAPER STEM STANDARD OFFSET, SZ 5
00841176100367ENCINA TAPER STEM STANDARD OFFSET, SZ 4
00841176100350ENCINA TAPER STEM STANDARD OFFSET, SZ 3
00841176100343ENCINA TAPER STEM STANDARD OFFSET, SZ 2
00841176100336ENCINA TAPER STEM STANDARD OFFSET, SZ 1
00841176100329ENCINA TAPER STEM STANDARD OFFSET, SZ 0

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