STERILE SPINE ACP SYSTEM

GUDID B562ACP751028US0

Sterile Spine AC Plate, 1 Level, 28 mm

WISHBONE MEDICAL, INC.

Spinal fixation plate, non-bioabsorbable
Primary Device IDB562ACP751028US0
NIH Device Record Key9eb14a2d-aa7f-4d21-b701-2244737b1ac1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTERILE SPINE ACP SYSTEM
Version Model NumberACP75-1028-US
Company DUNS062355158
Company NameWISHBONE MEDICAL, 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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB562ACP751028US0 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-11
Device Publish Date2020-08-03

On-Brand Devices [STERILE SPINE ACP SYSTEM]

B562ACP751020US0Sterile Spine AC Plate, 1 Level, 20 mm
B562ACP755140016US0Sterile Spine ACP Screw, VA/SD, Ø4.0x16 mm
B562ACP755140014US0Sterile Spine ACP Screw, VA/SD, Ø4.0x14 mm
B562ACP755140012US0Sterile Spine ACP Screw, VA/SD, Ø4.0x12 mm
B562ACP755140010US0Sterile Spine ACP Screw, VA/SD, Ø4.0x10 mm
B562ACP752052US0Sterile Spine AC Plate, 2 Level, 52 mm
B562ACP752049US0Sterile Spine AC Plate, 2 Level, 49 mm
B562ACP752046US0Sterile Spine AC Plate, 2 Level, 46 mm
B562ACP752043US0Sterile Spine AC Plate, 2 Level, 43 mm
B562ACP752040US0Sterile Spine AC Plate, 2 Level, 40 mm
B562ACP752037US0Sterile Spine AC Plate, 2 Level, 37 mm
B562ACP752034US0Sterile Spine AC Plate, 2 Level, 34 mm
B562ACP751032US0Sterile Spine AC Plate, 1 Level, 32 mm
B562ACP751030US0Sterile Spine AC Plate, 1 Level, 30 mm
B562ACP751028US0Sterile Spine AC Plate, 1 Level, 28 mm
B562ACP751026US0Sterile Spine AC Plate, 1 Level, 26 mm
B562ACP751024US0Sterile Spine AC Plate, 1 Level, 24 mm
B562ACP751022US0Sterile Spine AC Plate, 1 Level, 22 mm
B562ACP756145020US0Sterile Spine ACP Screw, FA/SD, Ø4.5x20 mm
B562ACP756145018US0Sterile Spine ACP Screw, FA/SD, Ø4.5x18 mm
B562ACP756145016US0Sterile Spine ACP Screw, FA/SD, Ø4.5x16 mm
B562ACP756145014US0Sterile Spine ACP Screw, FA/SD, Ø4.5x14 mm
B562ACP756145012US0Sterile Spine ACP Screw, FA/SD, Ø4.5x12 mm
B562ACP756145010US0Sterile Spine ACP Screw, FA/SD, Ø4.5x10 mm
B562ACP756140020US0Sterile Spine ACP Screw, FA/SD, Ø4.0x20 mm
B562ACP756140018US0Sterile Spine ACP Screw, FA/SD, Ø4.0x18 mm
B562ACP756140016US0Sterile Spine ACP Screw, FA/SD, Ø4.0x16 mm
B562ACP756140014US0Sterile Spine ACP Screw, FA/SD, Ø4.0x14 mm
B562ACP756140012US0Sterile Spine ACP Screw, FA/SD, Ø4.0x12 mm
B562ACP756140010US0Sterile Spine ACP Screw, FA/SD, Ø4.0x10 mm
B562ACP755145020US0Sterile Spine ACP Screw, VA/SD, Ø4.5x20 mm
B562ACP755145018US0Sterile Spine ACP Screw, VA/SD, Ø4.5x18 mm
B562ACP755145016US0Sterile Spine ACP Screw, VA/SD, Ø4.5x16 mm
B562ACP755145014US0Sterile Spine ACP Screw, VA/SD, Ø4.5x14 mm
B562ACP755145012US0Sterile Spine ACP Screw, VA/SD, Ø4.5x12 mm
B562ACP755145010US0Sterile Spine ACP Screw, VA/SD, Ø4.5x10 mm
B562ACP755140020US0Sterile Spine ACP Screw, VA/SD, Ø4.0x20 mm
B562ACP755140018US0Sterile Spine ACP Screw, VA/SD, Ø4.0x18 mm
B562KITACP751US0STERILE SPINE ACP Instrument Kit
B56251400200T15G10ACP Screw & Lock Driver - T15
B56251400100010G10ACP Drill - 10mm
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