Modal Total Hip System

GUDID B035M140006001

Taper Rasp, GBC Sz 6.0

MODAL MANUFACTURING LLC

Femoral stem prosthesis trial Femoral stem prosthesis trial
Primary Device IDB035M140006001
NIH Device Record Key2e260826-f341-437d-b48a-2a5c730edcf3
Commercial Distribution StatusIn Commercial Distribution
Brand NameModal Total Hip System
Version Model NumberM-1400-0600
Company DUNS081983825
Company NameMODAL MANUFACTURING LLC
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 Identifiers

Device Issuing AgencyDevice ID
HIBCCB035M140006001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B035M140006001]

Moist Heat or Steam Sterilization


[B035M140006001]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-02-07
Device Publish Date2018-07-01

On-Brand Devices [Modal Total Hip System]

B035MEBS65451Bone Screw, 6.5mm X 45mm
B035MEBS65401Bone Screw, 6.5mm X 40mm
B035MEBS65351Bone Screw, 6.5mm X 35mm
B035MEBS65301Bone Screw, 6.5mm X 30mm
B035MEBS65251Bone Screw, 6.5mm X 25mm
B035MEBS65201Bone Screw, 6.5mm X 20mm
B035MEBS65151Bone Screw, 6.5mm X 15mm
B035M150040011Dome Impactor Sz 40
B035M150036011Dome Impactor Sz 36
B035M150032011Dome Impactor Sz 32
B035M150028011Dome Impactor Sz 28
B035M150010171Calcar Planar
B035M150010161Cup Alignment Guide
B035M150010151Shell Impactor Spacer
B035M150010141Handle, Straight Reamer
B035M1500101313.5mm Pivot Driver
B035M150010121T-Handle Starter Awl
B035M150010111Osteo Cutter, Angled Box
B035M150010101Screw Forceps
B035M150010091Drill Guide
B035M150010081Flex Depth Gage
B035M150010071Flex Drill
B035M150010061Handle, Ratcheting In-Line
B035M150010051Handle, Straight Broach GBC
B035M150010041Handle, Head Impactor
B035M150010031Handle, Shell Impactor
B035M150010021Handle, Stem Extractor
B035M150010011Handle, Stem Impactor
B035M143528041Adapter, Trial 16/18 - 12/14 XL
B035M143528031Adapter, Trial 16/18 - 12/14 L
B035M143528021Adapter, Trial 16/18 - 12/14 M
B035M143528011Adapter, Trial 16/18 - 12/14 S
B035M142507221Trial Neck, Ext Sz 7.5 - 22.5
B035M141040001Femoral Option Head, Trial Sz 40
B035M141036001Femoral Option Head, Trial Sz 36
B035M141032001Femoral Option Head, Trial Sz 32
B035M141028001Femoral Option Head, Trial Sz 28
B035M140022501Taper Rasp, GBC Sz 22.5
B035M140020001Taper Rasp, GBC Sz 20.0
B035M140015001Taper Rasp, GBC Sz 15.0
B035M140013751Taper Rasp, GBC Sz 13.75
B035M140012501Taper Rasp, GBC Sz 12.5
B035M140011251Taper Rasp, GBC Sz 11.25
B035M140010001Taper Rasp, GBC Sz 10.0
B035M140008751Taper Rasp, GBC Sz 8.75
B035M140007501Taper Rasp, GBC Sz 7.5
B035M140006221Trial Neck, Std Sz 6.0 - 22.5
B035M140006001Taper Rasp, GBC Sz 6.0
B035M140000681Trial Shell, Cluster Hole Sz 68
B035M140000661Trial Shell, Cluster Hole Sz 66

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