Kyocera Medical Technologies, Inc. 1114-753-050

GUDID 00841523109890

Reduction Polyaxial Screw 7.5mm diameter 50mm length for use with a 6.0 Rod

KYOCERA MEDICAL TECHNOLOGIES, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00841523109890
NIH Device Record Keyccdb32d1-3baf-4ea8-b729-14c9f0d7151a
Commercial Distribution StatusIn Commercial Distribution
Brand NameKyocera Medical Technologies, Inc.
Version Model NumberS 100
Catalog Number1114-753-050
Company DUNS116995646
Company NameKYOCERA MEDICAL TECHNOLOGIES, 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841523109890 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAppliance, Fixation, Spinal Interlaminal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

[00841523109890]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-07-29
Device Publish Date2015-10-29

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0084152313005438 x 30 Implant Caddy, 7° PEEK
008415231198519mm Trial, 34 X 28, 12° Lordosis
008415231198449mm Trial, 30 X 26, 12° Lordosis
00841523146079Tesera T, Straight Trial 28mm x 10mm x 16mm, Bullet
00841523146062Tesera T, Straight Trial 28mm x 10mm x 15mm, Bullet
00841523146055Tesera T, Straight Trial 28mm x 10mm x 14mm, Bullet
00841523146048Tesera T, Straight Trial 28mm x 10mm x 13mm, Bullet
00841523146031Tesera T, Straight Trial 28mm x 10mm x 12mm, Bullet
00841523146024Tesera T, Straight Trial 28mm x 10mm x 11mm, Bullet
00841523146017Tesera T, Straight Trial 28mm x 10mm x 10mm, Bullet
00841523146000Tesera T, Straight Trial 28mm x 10mm x 9mm, Bullet
00841523145997Tesera T, Straight Trial 28mm x 10mm x 8mm, Bullet
00841523145980Tesera T, Straight Trial 28mm x 10mm x 7mm, Bullet
00841523150625Pituitary Rongeur, 4mm x 10mm
00841523150618Pituitary Rongeur, 4mm x 10mm
00841523150601Posterior Paddle Sizer, 15mm
00841523150595Posterior Paddle Sizer, 14mm
00841523150588Posterior Paddle Sizer, 13mm
00841523150571Posterior Paddle Sizer, 12mm
00841523150564Posterior Paddle Sizer, 11mm
00841523150557Posterior Paddle Sizer, 10mm
00841523150540Posterior Paddle Sizer, 9mm
00841523150533Posterior Paddle Sizer, 8mm
00841523150526Posterior Paddle Sizer, 7mm
00841523150519Posterior Paddle Sizer, 6mm
00841523150502Tesera C Cage Inserter
00841523150496Distal Femoral Cut Block
00841523150489Distal Femoral Alignment Guide Tower
00841523148622PS Box Gauge
00841523148615A200 PS Notch Cutting Guide, Size 7
00841523148608A200 PS Notch Cutting Guide, Size 6
00841523148592A200 PS Notch Cutting Guide, Size 5
00841523148585A200 PS Notch Cutting Guide, Size 4
00841523148578A200 PS Notch Cutting Guide, Size 3
00841523148561A200 PS Notch Cutting Guide, Size 2
00841523148554A200 PS Notch Cutting Guide, Size 1
00841523147649PS Tibia Insert Trial Size C, 23mm - Right
00841523147632PS Tibia Insert Trial Size C, 20mm - Right
00841523147625PS Tibia Insert Trial Size C, 17mm - Right
00841523147618PS Tibia Insert Trial Size C, 14mm - Right
00841523147601PS Tibia Insert Trial Size C, 12mm - Right
00841523147595PS Tibia Insert Trial Size C, 10mm - Right
00841523147588PS Tibia Insert Trial Size B, 23mm - Right
00841523147571PS Tibia Insert Trial Size B, 20mm - Right
00841523147564PS Tibia Insert Trial Size B, 17mm - Right
00841523147557PS Tibia Insert Trial Size B, 14mm - Right
00841523147540PS Tibia Insert Trial Size B, 12mm - Right
00841523147533PS Tibia Insert Trial Size B, 10mm - Right
00841523147526PS Tibia Insert Trial Size A, 23mm - Right
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