STERILE SPINE ACP SYSTEM

GUDID B562ACP756140016US0

Sterile Spine ACP Screw, FA/SD, Ø4.0x16 mm

WISHBONE MEDICAL, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device IDB562ACP756140016US0
NIH Device Record Keyaa4cdd06-6aa9-4573-b1e1-bc0453993577
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTERILE SPINE ACP SYSTEM
Version Model NumberACP75-6140-016-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
HIBCCB562ACP756140016US0 [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 Date2020-08-12
Device Publish Date2020-08-04

On-Brand Devices [STERILE SPINE ACP SYSTEM]

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B562ACP755140016US0Sterile Spine ACP Screw, VA/SD, Ø4.0x16 mm
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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
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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
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B562ACP755145010US0Sterile Spine ACP Screw, VA/SD, Ø4.5x10 mm
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