Paeon Posterior Cervical Fixation System 6201-5050

GUDID 00840273318798

Cervical Polyaxial Screw Ø5.0x50mm (Ø3.5 Neck)

Aegis Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840273318798
NIH Device Record Key7a76bd4a-1d0e-4155-b1c7-c8fe8e6853bd
Commercial Distribution StatusIn Commercial Distribution
Brand NamePaeon Posterior Cervical Fixation System
Version Model Number6201-5050
Catalog Number6201-5050
Company DUNS017993061
Company NameAegis Spine, 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840273318798 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKGPosterior Cervical Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840273318798]

Moist Heat or Steam Sterilization


[00840273318798]

Moist Heat or Steam Sterilization


[00840273318798]

Moist Heat or Steam Sterilization


[00840273318798]

Moist Heat or Steam Sterilization


[00840273318798]

Moist Heat or Steam Sterilization


[00840273318798]

Moist Heat or Steam Sterilization


[00840273318798]

Moist Heat or Steam Sterilization


[00840273318798]

Moist Heat or Steam Sterilization


[00840273318798]

Moist Heat or Steam Sterilization


[00840273318798]

Moist Heat or Steam Sterilization


[00840273318798]

Moist Heat or Steam Sterilization


[00840273318798]

Moist Heat or Steam Sterilization


[00840273318798]

Moist Heat or Steam Sterilization


[00840273318798]

Moist Heat or Steam Sterilization


[00840273318798]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-06
Device Publish Date2022-08-29

On-Brand Devices [Paeon Posterior Cervical Fixation System]

00840273305613Cervical Semi Reduction Screw Ø4.0x50mm (Ø2.4 Neck)
00840273305606Cervical Semi Reduction Screw Ø4.0x48mm (Ø2.4 Neck)
00840273305590Cervical Semi Reduction Screw Ø4.0x46mm (Ø2.4 Neck)
00840273305583Cervical Semi Reduction Screw Ø4.0x44mm (Ø2.4 Neck)
00840273305576Cervical Semi Reduction Screw Ø4.0x42mm (Ø2.4 Neck)
00840273305569Cervical Semi Reduction Screw Ø4.0x40mm (Ø2.4 Neck)
00840273305552Cervical Semi Reduction Screw Ø4.0x38mm (Ø2.4 Neck)
00840273305545Cervical Semi Reduction Screw Ø4.0x36mm (Ø2.4 Neck)
00840273305538Cervical Semi Reduction Screw Ø4.0x34mm (Ø2.4 Neck)
00840273305521Cervical Semi Reduction Screw Ø4.0x32mm (Ø2.4 Neck)
00840273305514Cervical Semi Reduction Screw Ø4.0x30mm (Ø2.4 Neck)
00840273305507Cervical Semi Reduction Screw Ø4.0x28mm (Ø2.4 Neck)
00840273305491Cervical Semi Reduction Screw Ø4.0x26mm (Ø2.4 Neck)
00840273305484Cervical Semi Reduction Screw Ø4.0x24mm (Ø2.4 Neck)
00840273305477Cervical Semi Reduction Screw Ø4.0x22mm (Ø2.4 Neck)
00840273305460Cervical Semi Reduction Screw Ø4.0x20mm (Ø2.4 Neck)
00840273305453Cervical Semi Reduction Screw Ø4.0x18mm (Ø2.4 Neck)
00840273305446Cervical Semi Reduction Screw Ø4.0x16mm (Ø2.4 Neck)
00840273305439Cervical Semi Reduction Screw Ø4.0x14mm (Ø2.4 Neck)
00840273305422Cervical Semi Reduction Screw Ø4.0x12mm (Ø2.4 Neck)
00840273305415Cervical Semi Reduction Screw Ø4.0x10mm (Ø2.4 Neck)
00840273305408Cervical Semi Reduction Screw Ø3.5x50mm (Ø2.4 Neck)
00840273305392Cervical Semi Reduction Screw Ø3.5x48mm (Ø2.4 Neck)
00840273305385Cervical Semi Reduction Screw Ø3.5x46mm (Ø2.4 Neck)
00840273305378Cervical Semi Reduction Screw Ø3.5x44mm (Ø2.4 Neck)
00840273305361Cervical Semi Reduction Screw Ø3.5x42mm (Ø2.4 Neck)
00840273305354Cervical Semi Reduction Screw Ø3.5x40mm (Ø2.4 Neck)
00840273305347Cervical Semi Reduction Screw Ø3.5x38mm (Ø2.4 Neck)
00840273305330Cervical Semi Reduction Screw Ø3.5x36mm (Ø2.4 Neck)
00840273305323Cervical Semi Reduction Screw Ø3.5x34mm (Ø2.4 Neck)
00840273305316Cervical Semi Reduction Screw Ø3.5x32mm (Ø2.4 Neck)
00840273305309Cervical Semi Reduction Screw Ø3.5x30mm (Ø2.4 Neck)
00840273305293Cervical Semi Reduction Screw Ø3.5x28mm (Ø2.4 Neck)
00840273305286Cervical Semi Reduction Screw Ø3.5x26mm (Ø2.4 Neck)
00840273305279Cervical Semi Reduction Screw Ø3.5x24mm (Ø2.4 Neck)
00840273305262Cervical Semi Reduction Screw Ø3.5x22mm (Ø2.4 Neck)
00840273305255Cervical Semi Reduction Screw Ø3.5x20mm (Ø2.4 Neck)
00840273305248Cervical Semi Reduction Screw Ø3.5x18mm (Ø2.4 Neck)
00840273305231Cervical Semi Reduction Screw Ø3.5x16mm (Ø2.4 Neck)
00840273305224Cervical Semi Reduction Screw Ø3.5x14mm (Ø2.4 Neck)
00840273305217Cervical Semi Reduction Screw Ø3.5x12mm (Ø2.4 Neck)
00840273305200Cervical Semi Reduction Screw Ø3.5x10mm (Ø2.4 Neck)
00840273305194Cervical Polyaxial Screw Ø4.0x50mm (Ø3.0 Neck)
00840273305187Cervical Polyaxial Screw Ø4.0x48mm (Ø3.0 Neck)
00840273305170Cervical Polyaxial Screw Ø4.0x46mm (Ø3.0 Neck)
00840273305163Cervical Polyaxial Screw Ø4.0x44mm (Ø3.0 Neck)
00840273305156Cervical Polyaxial Screw Ø4.0x42mm (Ø3.0 Neck)
00840273305149Cervical Polyaxial Screw Ø4.0x40mm (Ø3.0 Neck)
00840273305132Cervical Polyaxial Screw Ø4.0x38mm (Ø3.0 Neck)
00840273305125Cervical Polyaxial Screw Ø4.0x36mm (Ø3.0 Neck)

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