Defender™ Anterior Cervical Plate System 15-5638

GUDID 10840642167351

Fixed Self-Drilling Screw, ø4.35 mm X 18 mm

Spine Wave, Inc.

Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable
Primary Device ID10840642167351
NIH Device Record Key3540cae4-ce6f-4054-be5a-25e1fbf631aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameDefender™ Anterior Cervical Plate System
Version Model Number15-5638
Catalog Number15-5638
Company DUNS067789763
Company NameSpine Wave, 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com

Device Dimensions

Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter
Outer Diameter4.35 Millimeter
Length18 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110840642167351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

[10840642167351]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-16
Device Publish Date2021-08-06

On-Brand Devices [Defender™ Anterior Cervical Plate System]

10840642167276Fixed Self-Drilling Screw, ø4.35 mm X 10 mm
10840642167269Fixed Self-Drilling Screw, ø4.0 mm X 22 mm
10840642167252Fixed Self-Drilling Screw, ø4.0 mm X 20 mm
10840642167238Fixed Self-Drilling Screw, ø4.0 mm X 18 mm
10840642167214Fixed Self-Drilling Screw, ø4.0 mm X 16 mm
10840642167191Fixed Self-Drilling Screw, ø4.0 mm X 14 mm
10840642167177Fixed Self-Drilling Screw, ø4.0 mm X 12 mm
10840642167153Fixed Self-Drilling Screw, ø4.0 mm X 10 mm
108406421671465 Level Plate, 91 mm
108406421671395 Level Plate, 86 mm
108406421671225 Level Plate, 81 mm
108406421671155 Level Plate, 76 mm
108406421671085 Level Plate, 71 mm
108406421670924 Level Plate, 78 mm
108406421670854 Level Plate, 74 mm
108406421670784 Level Plate, 70 mm
108406421670614 Level Plate, 66 mm
108406421670544 Level Plate, 62 mm
108406421670474 Level Plate, 58 mm
108406421670304 Level Plate, 54 mm
108406421670234 Level Plate, 50 mm
108406421670164 Level Plate, 46 mm
108406421670093 Level Plate, 69 mm
108406421669963 Level Plate, 66 mm
108406421669893 Level Plate, 63 mm
108406421669723 Level Plate, 60 mm
108406421669653 Level Plate, 57 mm
108406421669583 Level Plate, 54 mm
108406421669413 Level Plate, 51 mm
108406421669343 Level Plate, 48 mm
108406421669273 Level Plate, 45 mm
108406421669103 Level Plate, 42 mm
108406421669033 Level Plate, 39 mm
108406421668973 Level Plate, 36 mm
108406421668802 Level Plate, 46 mm
108406421668732 Level Plate, 44 mm
108406421668662 Level Plate, 42 mm
108406421668592 Level Plate, 40 mm
108406421668422 Level Plate, 38 mm
108406421668352 Level Plate, 36 mm
108406421668282 Level Plate, 34 mm
108406421668112 Level Plate, 32 mm
108406421668042 Level Plate, 30 mm
108406421667982 Level Plate, 28 mm
108406421667812 Level Plate, 26 mm
108406421667742 Level Plate, 24 mm
108406421667672 Level Plate, 22 mm
108406421667501 Level Plate, 26 mm
108406421667431 Level Plate, 24 mm
108406421667361 Level Plate, 22 mm

Trademark Results [Defender]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DEFENDER
DEFENDER
98472653 not registered Live/Pending
Engineered Custom Coatings, LLC
2024-03-28
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98403860 not registered Live/Pending
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2024-02-13
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98393766 not registered Live/Pending
Parcel Safe Systems LLC
2024-02-06
DEFENDER
DEFENDER
98389343 not registered Live/Pending
Alpha Nutra, LLC
2024-02-02
DEFENDER
DEFENDER
98051223 not registered Live/Pending
SpillTech Holding Company
2023-06-20
DEFENDER
DEFENDER
97831665 not registered Live/Pending
Pyramid Design & Manufacturing
2023-03-09
DEFENDER
DEFENDER
97697524 not registered Live/Pending
Clearview Systems, LLC
2022-11-30
DEFENDER
DEFENDER
97693904 not registered Live/Pending
Bunzl IP Holdings, LLC
2022-11-28
DEFENDER
DEFENDER
97479198 not registered Live/Pending
Currax Pharmaceuticals LLC
2022-06-28
DEFENDER
DEFENDER
97313847 not registered Live/Pending
Defender Operations, LLC
2022-03-15
DEFENDER
DEFENDER
97307484 not registered Live/Pending
Ralco Nutrition, Inc.
2022-03-11
DEFENDER
DEFENDER
97174496 not registered Live/Pending
Foot Defender, LLC
2021-12-16
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