Humelock Reversed Shoulder 903-4014

GUDID 03701037304693

TRIAL HUMELOCK REVERSED STEM Ø40/14

FX SOLUTIONS

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID03701037304693
NIH Device Record Key78dd354f-97ed-466d-8c76-574ac309ae1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameHumelock Reversed Shoulder
Version Model Number903-4014
Catalog Number903-4014
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 Usefalse
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 Diameter14 Millimeter
Outer Diameter40 Millimeter
Outer Diameter14 Millimeter
Outer Diameter40 Millimeter
Outer Diameter14 Millimeter
Outer Diameter40 Millimeter
Outer Diameter14 Millimeter
Outer Diameter40 Millimeter
Outer Diameter14 Millimeter
Outer Diameter40 Millimeter
Outer Diameter14 Millimeter
Outer Diameter40 Millimeter
Outer Diameter14 Millimeter
Outer Diameter40 Millimeter
Outer Diameter14 Millimeter
Outer Diameter40 Millimeter
Outer Diameter14 Millimeter
Outer Diameter40 Millimeter
Outer Diameter14 Millimeter
Outer Diameter40 Millimeter
Outer Diameter14 Millimeter
Outer Diameter40 Millimeter
Outer Diameter14 Millimeter
Outer Diameter40 Millimeter
Outer Diameter14 Millimeter
Outer Diameter40 Millimeter
Outer Diameter14 Millimeter
Outer Diameter40 Millimeter
Outer Diameter14 Millimeter
Outer Diameter40 Millimeter
Outer Diameter14 Millimeter
Outer Diameter40 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS103701037304693 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03701037304693]

Moist Heat or Steam Sterilization

[03701037304693]

Moist Heat or Steam Sterilization

[03701037304693]

Moist Heat or Steam Sterilization

[03701037304693]

Moist Heat or Steam Sterilization

[03701037304693]

Moist Heat or Steam Sterilization

[03701037304693]

Moist Heat or Steam Sterilization

[03701037304693]

Moist Heat or Steam Sterilization

[03701037304693]

Moist Heat or Steam Sterilization

[03701037304693]

Moist Heat or Steam Sterilization

[03701037304693]

Moist Heat or Steam Sterilization

[03701037304693]

Moist Heat or Steam Sterilization

[03701037304693]

Moist Heat or Steam Sterilization

[03701037304693]

Moist Heat or Steam Sterilization

[03701037304693]

Moist Heat or Steam Sterilization

[03701037304693]

Moist Heat or Steam Sterilization

[03701037304693]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-10-08
Device Publish Date2017-12-14

On-Brand Devices [Humelock Reversed Shoulder]

03701037307229HUMELOCK REVERSED EXTRACTOR
03701037307205HUMELOCK REVERSED CUTTING GUIDES HOLDER SCREW
03701037306390SHORT T-HANDLE / AO
03701037306376SPACER TRIAL +9 mm
03701037306369HUMELOCK REVERSED EPIPHYSEAL RASP Ø40mm
03701037306352HUMELOCK REVERSED EPIPHYSEAL RASP Ø36mm
03701037306345HUMELOCK REVERSED EPIPHYSEAL RASP Ø32mm
03701037306338HUMELOCK REVERSED METAPHYSEAL RASP Ø40mm
03701037306321HUMELOCK REVERSED METAPHYSEAL RASP Ø36mm
03701037306314HUMELOCK REVERSED METAPHYSEAL RASP Ø32mm
03701037306307HUMELOCK REVERSED WRENCH
03701037306291HUMELOCK REVERSED REAMER Ø20mm
03701037306284HUMELOCK REVERSED REAMER Ø18mm
03701037306277HUMELOCK REVERSED REAMER Ø16mm
03701037306260HUMELOCK REVERSED REAMER Ø15mm
03701037306253HUMELOCK REVERSED REAMER Ø14mm
03701037306246HUMELOCK REVERSED REAMER Ø13mm
03701037306239HUMELOCK REVERSED REAMER Ø12mm
03701037306222HUMELOCK REVERSED REAMER Ø11mm
03701037306215HUMELOCK REVERSED REAMER Ø10mm
03701037306208HUMELOCK REVERSED REAMER Ø9mm
03701037306192HUMELOCK REVERSED REAMER Ø8mm
03701037306185HUMELOCK REVERSED T HANDLE / AO
03701037306178HUMELOCK REVERSED TRIANGULAR AWL
03701037306161RATCHET HANDLE
03701037306116INFERIOR GLENOID RETRACTOR
03701037306109SUPERIOR GLENOID RETRACTOR
03701037306093ANTERIOR GLENOID RETRACTOR
03701037306086DRILL BIT Ø07mm / AO EXT. POST +10mm
03701037306079DRILL BIT Ø07mm / AO EXT. POST +6mm
03701037306062HUMELOCK REVERSED GLENOSPHERE CLAMP DELTO PECTORAL
03701037306055HUMELOCK REVERSED GLENOSPHERE HOLDER
03701037306048EXTENSION
03701037306031HUMELOCK REVERSED PIN EXTRACTOR
03701037306024HUMELOCK REVERSED HAMMER
03701037306017HUMELOCK REVERSED ARCH Ø40
03701037306000HUMELOCK REVERSED ARCH Ø36
03701037305997HUMELOCK REVERSED GLENOID MANUAL REAMER Ø36mm
03701037305980GLENOID RESURFACING REAMER Ø36 mm/ AO
03701037305973GLENOID RESURFACING REAMER Ø40 mm/ AO
03701037305966DRILL BIT Ø3.2 mm L.250mm/AO
03701037305935HUMELOCK REVERSED SCREW / AIMER
03701037305928HUMELOCK REVERSED AIMER
03701037305911HUMELOCK REVERSED BASE PLATE IMPACTOR
03701037305904HUMELOCK REVERSED GLENOID MANUAL REAMER Ø40mm
03701037305898HUMELOCK REVERSED GLENOID RESURFACING REAMER Ø24mm / AO
03701037305881HUMELOCK REVERSED GUIDES HOLDER
03701037305867HUMELOCK REVERSED END ROD CUP IMPACTOR
03701037305850HUMELOCK REVERSED HANDLE CUP IMPACTOR
03701037305843HUMELOCK REVERSED STEM IMPACTOR
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