Seitz Solution Radial Head KCW-61

GUDID B033KCW61

6x1mm Spacer

Kapp Surgical Instrument Co.

Elbow radius prosthesis
Primary Device IDB033KCW61
NIH Device Record Keyccc03f39-beac-473d-a941-2d72be5f7aed
Commercial Distribution StatusIn Commercial Distribution
Brand NameSeitz Solution Radial Head
Version Model NumberKCW-61
Catalog NumberKCW-61
Company DUNS004171112
Company NameKapp Surgical Instrument Co.
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB033KCW61 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWIProsthesis, Elbow, Hemi-, Radial, Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B033KCW61]

Moist Heat or Steam Sterilization


[B033KCW61]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [Seitz Solution Radial Head]

B033KCW929x2mm Spacer
B033KCW919x1mm Spacer
B033KCW828x2mm Spacer
B033KCW818x1mm Spacer
B033KCW727x2mm Spacer
B033KCW717x1mm Spacer
B033KCW626x2mm Spacer
B033KCW616x1mm Spacer
B033KCW525x2mm Spacer
B033KCW515x1mm Spacer
B033KCSI9259x25.5mm Stem
B033KCSI8248x24mm Stem
B033KCSI7227x22mm Stem
B033KCSI6216x21mm Stem
B033KCSI5195x19mm Stem
B033KCHI261626x16mm Radial Head
B033KCHI261426x14mm Radial Head
B033KCHI261226x12mm Radial Head
B033KCHI231523x15mm Radial Head
B033KCHI231323x13mm Radial Head
B033KCHI231123x11mm Radial Head
B033KCHI201420x14mm Radial Head
B033KCHI201220x12mm Radial Head
B033KCHI201020x10mm Radial Head
B033KCHI181318 x 13mm Radial Head
B033KCHI181118 x 11mm Radial Head
B033KCHI180918 x 9mm Radial Head

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