ENCINA TAPER FEMORAL STEM HIGH OFFSET 110-10-009

GUDID 00841176100527

ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 9

STINSON ORTHOPEDICS INC.

Coated hip femur prosthesis, modular
Primary Device ID00841176100527
NIH Device Record Key7f929ac0-ea5a-42b1-85db-623184313eea
Commercial Distribution StatusIn Commercial Distribution
Brand NameENCINA TAPER FEMORAL STEM HIGH OFFSET
Version Model Number110-10-009
Catalog Number110-10-009
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
GS100841176100527 [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 HIGH OFFSET]

00841176101500ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 12
00841176101494ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 11
00841176100534ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 10
00841176100527ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 9
00841176100510ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 8
00841176100503ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 7
00841176100497ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 6
00841176100480ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 5
00841176100473ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 4
00841176100466ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 3
00841176100459ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 2
00841176100442ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 1
00841176100435ENCINA TAPER FEMORAL STEM HIGH OFFSET, SZ 0

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