Summa Orthopaedics Ankle Distal Tibia System Bone Plate

GUDID 08800089408795

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID08800089408795
NIH Device Record Key29dbe959-be9c-430b-85be-bc800d0e7eb4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSumma Orthopaedics Ankle Distal Tibia System Bone Plate
Version Model NumberSO-35-DLTB-010-L
Company DUNS688811603
Company NameJeil Medical Corporation
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
GS108800089408795 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800089408795]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-02-19
Device Publish Date2021-05-28

On-Brand Devices [Summa Orthopaedics Ankle Distal Tibia System Bone Plate]

08800089408924SO-35-DMTB-014-R
08800089408917SO-35-DMTB-014-L
08800089408900SO-35-DMTB-012-R
08800089408894SO-35-DMTB-012-L
08800089408887SO-35-DMTB-010-R
08800089408870SO-35-DMTB-010-L
08800089408863SO-35-DMTB-008-R
08800089408856SO-35-DMTB-008-L
08800089408849SO-35-DMTB-006-R
08800089408832SO-35-DMTB-006-L
08800089408825SO-35-DMTB-004-R
08800089408818SO-35-DMTB-004-L
08800089408801SO-35-DLTB-010-R
08800089408795SO-35-DLTB-010-L
08800089408788SO-35-DLTB-008-R
08800089408771SO-35-DLTB-008-L
08800089408764SO-35-DLTB-006-R
08800089408757SO-35-DLTB-006-L
08800089408740SO-35-DLTB-004-R
08800089408733SO-35-DLTB-004-L
08800089408726SO-35-DLTB-003-R
08800089408719SO-35-DLTB-003-L

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