Summa Orthopaedics System Bone Screw

GUDID 08806390885904

Jeil Medical Corporation

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID08806390885904
NIH Device Record Keycc3cd6df-3ce6-460f-98da-7d7a79f91370
Commercial Distribution StatusIn Commercial Distribution
Brand NameSumma Orthopaedics System Bone Screw
Version Model NumberSO-25P-SO-012-TA
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
GS108806390885904 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806390885904]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-24
Device Publish Date2020-04-16

On-Brand Devices [Summa Orthopaedics System Bone Screw]

08806390869317SO-25-HF-030
08806390869300SO-25-HF-028
08806390869294SO-25-HF-026
08806390869287SO-25-HF-024
08806390869270SO-25-HF-022
08806390869263SO-25-HF-020
08806390869256SO-25-HF-018
08806390869249SO-25-HF-016
08806390869232SO-25-HF-014
08806390869225SO-25-HF-012
08806390869218SO-25-HF-010
08806390869201SO-25-HF-008
08806390869195SO-161.032530
08806390869188SO-161.032528
08806390869171SO-161.032526
08806390869164SO-161.032524
08806390869157SO-161.032522
08806390869140SO-161.032520
08806390869133SO-161.032518
08806390869126SO-161.032516
08806390869119SO-161.032514
08806390869102SO-161.032512
08806390869096SO-161.032510
08806390869089SO-161.032508
0880639088364140_WASHER_Ø7.0
0880639088363440_NON_CANNULATED_NOR_STARIX_70MM
0880639088361040_NON_CANNULATED_NOR_STARIX_62MM
0880639088360340_NON_CANNULATED_NOR_STARIX_58MM
0880639088359740_NON_CANNULATED_NOR_STARIX_54MM
0880639088358040_NON_CANNULATED_NOR_STARIX_50MM
0880639088357340_NON_CANNULATED_NOR_STARIX_46MM
0880639088356640_NON_CANNULATED_NOR_STARIX_42MM
0880639088355940_NON_CANNULATED_NOR_STARIX_38MM
0880639088354240_NON_CANNULATED_NOR_STARIX_34MM
0880639088353540_NON_CANNULATED_NOR_STARIX_30MM
0880639088352840_NON_CANNULATED_NOR_STARIX_28MM
0880639088351140_NON_CANNULATED_NOR_STARIX_26MM
0880639088350440_NON_CANNULATED_NOR_STARIX_24MM
0880639088349840_NON_CANNULATED_NOR_STARIX_22MM
0880639088348140_NON_CANNULATED_NOR_STARIX_20MM
08806390865838SO-111-069-2
08806390865821SO-111-069-1
08806390874854SO-25L-SO-026-TA
08806390868198SO-15L-HF-012
08806390868174SO-15L-HF-010
08806390868150SO-15L-HF-008
08806390867993SO-25-SO-024-TA
08806390867986SO-25-SO-022-TA
08806390867979SO-25-SO-020-TA
08806390867962SO-25-SO-018-TA

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.