K2M Fenestrated Tap System SP-4029-05

GUDID 10888857461321

Tap, Fenestrated, Size Ø7.5

K2M, INC.

Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID10888857461321
NIH Device Record Key0916b825-cf22-4770-abda-14fbc35a4454
Commercial Distribution StatusIn Commercial Distribution
Brand NameK2M Fenestrated Tap System
Version Model NumberSP-4029-05
Catalog NumberSP-4029-05
Company DUNS146060863
Company NameK2M, INC.
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com

Device Dimensions

Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110888857461321 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWINSTRUMENT, BIOPSY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

[10888857461321]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-03
Device Publish Date2020-01-24

On-Brand Devices [K2M Fenestrated Tap System]

10888857183148Tap, Fenestrated, Size Ø8.5 mm
10888857183131Tap, Fenestrated, Size Ø7.5 mm
10888857183124Tap, Fenestrated, Size Ø6.5 mm
10888857183117Tap, Fenestrated, Size Ø5.5 mm
10888857183100Tap, Fenestrated, Size Ø4.5 mm
10888857183094Tap, Fenestrated, Size Ø4.0 mm
10888857461338Tap, Fenestrated, Size Ø8.5
10888857461321Tap, Fenestrated, Size Ø7.5
10888857461314Tap, Fenestrated, Size Ø6.5
10888857461307Tap, Fenestrated, Size Ø5.5
10888857461291Tap, Fenestrated, Size Ø4.5
10888857461284Tap, Fenestrated, Size Ø3.5
10888857530096Tap, Fenestrated Size Ø8.5
10888857530089Tap, Fenestrated Size Ø7.5
10888857530072Tap, Fenestrated Size Ø6.5
10888857530065Tap, Fenestrated Size Ø5.5
10888857530058Tap, Fenestrated Size Ø4.5
10888857530041Tap, Fenestrated Size Ø4.0
10888857183087Fenestrated Tap Adapter Quick Connect
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