White Pearl Preferred Angle ACP 2100-2122

GUDID B06221002122

WHT PEARL CERV PLATE, 2-LEVEL, 22mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

Metallic spinal interbody fusion cage
Primary Device IDB06221002122
NIH Device Record Key4c294461-1e52-486b-be45-37a755ea721e
Commercial Distribution StatusIn Commercial Distribution
Brand NameWhite Pearl Preferred Angle ACP
Version Model Number2100-2122
Catalog Number2100-2122
Company DUNS933442068
Company NameOsseus Fusion Systems, LLC
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-330-5960
EmailInfo@osseus.com
Phone888-330-5960
EmailInfo@osseus.com

Device Dimensions

Width17.5 Millimeter
Width17.5 Millimeter
Width17.5 Millimeter
Width17.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB06221002122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B06221002122]

Moist Heat or Steam Sterilization

[B06221002122]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2017-01-11

On-Brand Devices [White Pearl Preferred Angle ACP]

B0622109820CERV SCREW, FIXED, SELF-TAPPING, 4.25x20mm, CORT/CANC, PREF ACP
B0622109818CERV SCREW, FIXED, SELF-TAPPING, 4.25x18mm, CORT/CANC, PREF ACP
B0622109816CERV SCREW, FIXED, SELF-TAPPING, 4.25x16mm, CORT/CANC, PREF ACP
B0622109814CERV SCREW, FIXED, SELF-TAPPING, 4.25x14mm, CORT/CANC, PREF ACP
B0622109812CERV SCREW, FIXED, SELF-TAPPING, 4.25x12mm, CORT/CANC, PREF ACP
B0622109810CERV SCREW, FIXED, SELF-TAPPING, 4.25x10mm, CORT/CANC, PREF ACP
B0622109720CERV SCREW, VARIABLE, SELF-TAPPING, 4.25x20mm, CORT/CANC, PREF ACP
B0622109718CERV SCREW, VARIABLE, SELF-TAPPING, 4.25x18mm, CORT/CANC, PREF ACP
B0622109716CERV SCREW, VARIABLE, SELF-TAPPING, 4.25x16mm, CORT/CANC, PREF ACP
B0622109714CERV SCREW, VARIABLE, SELF-TAPPING, 4.25x14mm, CORT/CANC, PREF ACP
B0622109712CERV SCREW, VARIABLE, SELF-TAPPING, 4.25x12mm, CORT/CANC, PREF ACP
B0622109710CERV SCREW, VARIABLE, SELF-TAPPING, 4.25x10mm, CORT/CANC, PREF ACP
B0622109620CERV SCREW, FIXED, SELF-DRILLING, 4.25x20mm, CORT/CANC, PREF ACP
B0622109618CERV SCREW, FIXED, SELF-DRILLING, 4.25x18mm, CORT/CANC, PREF ACP
B0622109616CERV SCREW, FIXED, SELF-DRILLING, 4.25x16mm, CORT/CANC, PREF ACP
B0622109614CERV SCREW, FIXED, SELF-DRILLING, 4.25x14mm, CORT/CANC, PREF ACP
B0622109612CERV SCREW, FIXED, SELF-DRILLING, 4.25x12mm, CORT/CANC, PREF ACP
B0622109610CERV SCREW, FIXED, SELF-DRILLING, 4.25x10mm, CORT/CANC, PREF ACP
B0622109520CERV SCREW, VARIABLE, SELF-DRILLING, 4.25x20mm, CORT/CANC, PREF ACP
B0622109518CERV SCREW, VARIABLE, SELF-DRILLING, 4.25x18mm, CORT/CANC, PREF ACP
B0622109516CERV SCREW, VARIABLE, SELF-DRILLING, 4.25x16mm, CORT/CANC, PREF ACP
B0622109514CERV SCREW, VARIABLE, SELF-DRILLING, 4.25x14mm, CORT/CANC, PREF ACP
B0622109512CERV SCREW, VARIABLE, SELF-DRILLING, 4.25x12mm, CORT/CANC, PREF ACP
B0622109510CERV SCREW, VARIABLE, SELF-DRILLING, 4.25x10mm, CORT/CANC, PREF ACP
B0622109420CERV SCREW, FIXED, SELF-TAPPING, 3.75x20mm, CORT/CANC, PREF ACP
B0622109418CERV SCREW, FIXED, SELF-TAPPING, 3.75x18mm, CORT/CANC, PREF ACP
B0622109416CERV SCREW, FIXED, SELF-TAPPING, 3.75x16mm, CORT/CANC, PREF ACP
B0622109414CERV SCREW, FIXED, SELF-TAPPING, 3.75x14mm, CORT/CANC, PREF ACP
B0622109412CERV SCREW, FIXED, SELF-TAPPING, 3.75x12mm, CORT/CANC, PREF ACP
B0622109410CERV SCREW, FIXED, SELF-TAPPING, 3.75x10mm, CORT/CANC, PREF ACP
B0622109320CERV SCREW, VARIABLE, SELF-TAPPING, 3.75x20mm, CORT/CANC, PREF ACP
B0622109318CERV SCREW, VARIABLE, SELF-TAPPING, 3.75x18mm, CORT/CANC, PREF ACP
B0622109316CERV SCREW, VARIABLE, SELF-TAPPING, 3.75x16mm, CORT/CANC, PREF ACP
B0622109314CERV SCREW, VARIABLE, SELF-TAPPING, 3.75x14mm, CORT/CANC, PREF ACP
B0622109312CERV SCREW, VARIABLE, SELF-TAPPING, 3.75x12mm, CORT/CANC, PREF ACP
B0622109310CERV SCREW, VARIABLE, SELF-TAPPING, 3.75x10mm, CORT/CANC, PREF ACP
B0622109220CERV SCREW, FIXED, SELF-DRILLING, 3.75x20mm, CORT/CANC, PREF ACP
B0622109218CERV SCREW, FIXED, SELF-DRILLING, 3.75x18mm, CORT/CANC, PREF ACP
B0622109216CERV SCREW, FIXED, SELF-DRILLING, 3.75x16mm, CORT/CANC, PREF ACP
B0622109214CERV SCREW, FIXED, SELF-DRILLING, 3.75x14mm, CORT/CANC, PREF ACP
B0622109212CERV SCREW, FIXED, SELF-DRILLING, 3.75x12mm, CORT/CANC, PREF ACP
B0622109210CERV SCREW, FIXED, SELF-DRILLING, 3.75x10mm, CORT/CANC, PREF ACP
B0622109120CERV SCREW, VARIABLE, SELF-DRILLING, 3.75x20mm, CORT/CANC, PREF ACP
B0622109118CERV SCREW, VARIABLE, SELF-DRILLING, 3.75x18mm, CORT/CANC, PREF ACP
B0622109116CERV SCREW, VARIABLE, SELF-DRILLING, 3.75x16mm, CORT/CANC, PREF ACP
B0622109114CERV SCREW, VARIABLE, SELF-DRILLING, 3.75x14mm, CORT/CANC, PREF ACP
B0622109112CERV SCREW, VARIABLE, SELF-DRILLING, 3.75x12mm, CORT/CANC, PREF ACP
B0622109110CERV SCREW, VARIABLE, SELF-DRILLING, 3.75x10mm, CORT/CANC, PREF ACP
B0622100820CERV SCREW, FIXED, SELF-TAPPING, 4.25x20mm, DBL LEAD, PREF ACP
B0622100818CERV SCREW, FIXED, SELF-TAPPING, 4.25x18mm, DBL LEAD, PREF ACP
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.