Humeris Shoulder 106-5403

GUDID 03701037300671

CENTERED SPACER TA6V Ø54 +3 mm 0°

FX SOLUTIONS

Shoulder humeral body prosthesis
Primary Device ID03701037300671
NIH Device Record Keya84b0f13-9010-4769-adf7-e04528356669
Commercial Distribution StatusIn Commercial Distribution
Brand NameHumeris Shoulder
Version Model Number106-5403
Catalog Number106-5403
Company DUNS263076196
Company NameFX SOLUTIONS
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter54 Millimeter
Outer Diameter54 Millimeter
Outer Diameter54 Millimeter
Outer Diameter54 Millimeter
Outer Diameter54 Millimeter
Outer Diameter54 Millimeter
Outer Diameter54 Millimeter
Outer Diameter54 Millimeter
Outer Diameter54 Millimeter
Outer Diameter54 Millimeter
Outer Diameter54 Millimeter
Outer Diameter54 Millimeter
Outer Diameter54 Millimeter
Outer Diameter54 Millimeter
Outer Diameter54 Millimeter
Outer Diameter54 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture

Device Identifiers

Device Issuing AgencyDevice ID
GS103701037300671 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-10-07
Device Publish Date2017-05-22

On-Brand Devices [Humeris Shoulder]

03701037307144PROTECTOR Ø39mm WITH SCREW
03701037307120TRIAL CENTERED SPACER Ø35 +5 mm 0°
03701037307113TRIAL CENTERED SPACER Ø35 +3 mm 0°
03701037306802GLENOID CLAMP
03701037306789STOP DRILL BIT Ø7.5 mm L.150 mm/AO
03701037306772STOP DRILL BIT Ø5.0 mm L.150 mm/AO
03701037306680PROTECTOR Ø39mm
03701037306673PROTECTOR WITH GUIDE Ø39mm
03701037306666RASP SIZE 19
03701037306659RASP SIZE 17
03701037306642RASP SIZE 20
03701037306635RASP SIZE 18
03701037306628RASP SIZE 16
03701037306611RASP SIZE 15
03701037306604RASP SIZE 14
03701037306598RASP SIZE 13
03701037306581RASP SIZE 12
03701037306574RASP SIZE 11
03701037306567RASP SIZE 10
03701037306550RASP SIZE 09
03701037306543RASP SIZE 08
03701037306499LEFT CUTTING GUIDES HOLDER
03701037306475RIGHT CUTTING GUIDES HOLDER
03701037305584DRILL BIT Ø3.2mm L.150mm/AO
03701037304600HUMERIS STEM TA6V SIZE 20 CEMENTLESS Ti/HA
03701037304594HUMERIS STEM TA6V SIZE 19 CEMENTLESS Ti/HA
03701037304587HUMERIS STEM TA6V SIZE 18 CEMENTLESS Ti/HA
03701037304570HUMERIS STEM TA6V SIZE 17 CEMENTLESS Ti/HA
03701037304563TRIAL HUMERIS STEM T20
03701037304556TRIAL HUMERIS STEM T19
03701037304549TRIAL HUMERIS STEM T18
03701037304532TRIAL HUMERIS STEM T17
03701037304525TRIAL HUMERIS STEM T16
03701037304518TRIAL HUMERIS STEM T15
03701037304501TRIAL HUMERIS STEM T14
03701037304495TRIAL HUMERIS STEM T13
03701037304488TRIAL HUMERIS STEM T12
03701037304471TRIAL HUMERIS STEM T11
03701037304464TRIAL HUMERIS STEM T10
03701037304457TRIAL HUMERIS STEM T09
03701037304440TRIAL HUMERIS STEM T08
03701037304433TRIAL HUMERIS STEM T07
03701037304426TRIAL HUMERIS STEM T06
03701037304419TRIAL 3-4 PEGS GLENOID SIZE L
03701037304402TRIAL 3-4 PEGS GLENOID SIZE M
03701037304396TRIAL 3-4 PEGS GLENOID SIZE S
03701037304389TRIAL 3-4 PEGS GLENOID SIZE XS
03701037304372TRIAL CENTERED SPACER Ø54 +5 mm 0°
03701037304365TRIAL CENTERED SPACER Ø54 +3 mm 0°
03701037304358TRIAL CENTERED SPACER Ø52 +5 mm 0°
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