PMO Plate

GUDID B014FPMOL27

EMINENT SPINE LLC

External orthopaedic fixation system, single-use, non-sterile
Primary Device IDB014FPMOL27
NIH Device Record Key062fbf0d-9c21-415d-a636-0db7fa6bec93
Commercial Distribution StatusIn Commercial Distribution
Brand NamePMO Plate
Version Model NumberFPMOL27
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
HIBCCB014FPMOL27 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

Moist Heat or Steam Sterilization


[B014FPMOL27]

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 [PMO Plate]

B014FPMOR45FPMOR45
B014FPMOR39FPMOR39
B014FPMOR33FPMOR33
B014FPMOR27FPMOR27
B014FPMOR21FPMOR21
B014FPMOL45FPMOL45
B014FPMOL39FPMOL39
B014FPMOL33FPMOL33
B014FPMOL27FPMOL27
B014FPMOL21FPMOL21

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