475315

GUDID EATO4753159

Cannulated screw 7.5, TL 32, L 115

aap Implantate AG

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device IDEATO4753159
NIH Device Record Keycaf47531-9709-474c-bb0c-dda9f2701314
Commercial Distribution StatusIn Commercial Distribution
Version Model Number475315
Catalog Number475315
Company DUNS328420633
Company Nameaap Implantate AG
Device Count1
DM Exempttrue
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
HIBCCEATO4753159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[EATO4753159]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-13

Devices Manufactured by aap Implantate AG

04042409240447 - NA2025-01-16 Drill CS 4.0, ø2.5, L 130, quick coupling, single use
04042409240454 - NA2025-01-16 Drill CS 4.5, ø3.0, L 130, quick coupling, single use
04042409240461 - NA2025-01-16 Drill CS 4.0, ø4.0, L 130, quick coupling, single use
04042409240478 - NA2025-01-16 Drill CS 4.5, ø4.5, L 130, quick coupling, single use
04042409240485 - NA2025-01-16 Cannulated drill CS 6.5, ø4.4, L 220, Hudson, single use
04042409240508 - NA2025-01-16 Countersink CS 6.5/7.5, Hudson
04042409240713 - NA2025-01-16 Parallel guide for K-wires, CS 6.5/7.5
04042409240744 - NA2025-01-16 Screwdriver cannulated CS 6.5/7.5, hex, ø5.0, Hudson

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