Ascential ACP 1 48804318A

GUDID 07613327122541

Variable Angle Self-Drilling Bone Screw Set

Stryker Corporation

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device ID07613327122541
NIH Device Record Key3c6024f0-2410-43ff-8ca0-e55c1fa3d3e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAscential ACP 1
Version Model Number48804318A
Catalog Number48804318A
Company DUNS149183167
Company NameStryker Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length18 Millimeter
Length18 Millimeter
Device Size Text, specify0
Length18 Millimeter
Device Size Text, specify0
Length18 Millimeter
Device Size Text, specify0
Length18 Millimeter
Device Size Text, specify0
Length18 Millimeter
Device Size Text, specify0
Length18 Millimeter
Device Size Text, specify0
Length18 Millimeter
Device Size Text, specify0
Length18 Millimeter
Device Size Text, specify0
Length18 Millimeter
Device Size Text, specify0
Length18 Millimeter
Device Size Text, specify0
Length18 Millimeter
Device Size Text, specify0
Length18 Millimeter
Device Size Text, specify0
Length18 Millimeter
Device Size Text, specify0
Length18 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327122541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-31
Device Publish Date2015-09-14

On-Brand Devices [Ascential ACP 1]

076133271228624 Level Anterior Cervical Plate
076133271228554 Level Anterior Cervical Plate
076133271228484 Level Anterior Cervical Plate
076133271228314 Level Anterior Cervical Plate
076133271228244 Level Anterior Cervical Plate
076133271228174 Level Anterior Cervical Plate
076133271228004 Level Anterior Cervical Plate
076133271227944 Level Anterior Cervical Plate
076133271227874 Level Anterior Cervical Plate
076133271227703 Level Anterior Cervical Plate
076133271227633 Level Anterior Cervical Plate
076133271227562 Level Anterior Cervical Plate
076133271227493 Level Anterior Cervical Plate
076133271227324 Level Anterior Cervical Plate
076133271227254 Level Anterior Cervical Plate
076133271227183 Level Anterior Cervical Plate
076133271227013 Level Anterior Cervical Plate
076133271226953 Level Anterior Cervical Plate
076133271226883 Level Anterior Cervical Plate
076133271226713 Level Anterior Cervical Plate
076133271226642 Level Anterior Cervical Plate
076133271226573 Level Anterior Cervical Plate
076133271226402 Level Anterior Cervical Plate
076133271226333 Level Anterior Cervical Plate
076133271226263 Level Anterior Cervical Plate
076133271226192 Level Anterior Cervical Plate
076133271226022 Level Anterior Cervical Plate
076133271225961 Level Anterior Cervical Plate
076133271225892 Level Anterior Cervical Plate
076133271225722 Level Anterior Cervical Plate
076133271225652 Level Anterior Cervical Plate
076133271225582 Level Anterior Cervical Plate
07613327122541Variable Angle Self-Drilling Bone Screw Set
07613327122534Locking Screw Sterile Packed
076133271225271 Level Anterior Cervical Plate
076133271225102 Level Anterior Cervical Plate
076133271225031 Level Anterior Cervical Plate
076133271224971 Level Anterior Cervical Plate
076133271224801 Level Anterior Cervical Plate
076133271224731 Level Anterior Cervical Plate
07613327122466Variable Angle Self-Drilling Bone Screw Set
07613327122459Variable Angle Self-Drilling Bone Screw Set
076133271224421 Level Anterior Cervical Plate
07613327122435Variable Angle Self-Drilling Bone Screw Set
07613327122428Variable Angle Self-Drilling Bone Screw Set
07613327122411Fixed Angle Self-Drilling Bone Screw Set
07613327122404Fixed Angle Self-Drilling Bone Screw Set
07613327122398Fixed Angle Self-Drilling Bone Screw Set
07613327122381Variable Angle Self-Tapping Bone Screw Set
07613327122374Fixed Angle Self-Drilling Bone Screw Set

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.