Metatarsal Plate

GUDID B014FMTR48

EMINENT SPINE LLC

External orthopaedic fixation system, single-use, non-sterile
Primary Device IDB014FMTR48
NIH Device Record Key0653efcf-fc15-4adc-8efa-8e622340eff7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMetatarsal Plate
Version Model NumberFMTR48
Company DUNS022576742
Company NameEMINENT SPINE 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
HIBCCB014FMTR48 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


[B014FMTR48]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-04-29
Device Publish Date2017-02-13

On-Brand Devices [Metatarsal Plate ]

B014FMTSR3FMTSR3
B014FMTSR2FMTSR2
B014FMTSR1FMTSR1
B014FMTSL3FMTSL3
B014FMTSL2FMTSL2
B014FMTSL1FMTSL1
B014FMTR56FMTR56
B014FMTR52FMTR52
B014FMTR48FMTR48
B014FMTR42FMTR42
B014FMTR36FMTR36
B014FMTR30FMTR30
B014FMTR24FMTR24
B014FMTR18FMTR18
B014FMTL56FMTL56
B014FMTL52FMTL52
B014FMTL48FMTL48
B014FMTL42FMTL42
B014FMTL36FMTL36
B014FMTL30FMTL30
B014FMTL24FMTL24
B014FMTL18FMTL18
B014FMT44FMT44
B014FMT40FMT40
B014FMT36FMT36
B014FMT30FMT30
B014FMT24FMT24
B014FMT18FMT18

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