Anterior Cervical Plate 3-Level 66mm ACP366

GUDID 00840019904889

Anterior Cervical Plate 3-Level 66mm

PRECISION SPINE, INC.

Spinal fixation plate, non-bioabsorbable
Primary Device ID00840019904889
NIH Device Record Keyc54070c9-ff7a-4f7d-bbc5-e354d781bd70
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnterior Cervical Plate 3-Level 66mm
Version Model NumberACP366
Catalog NumberACP366
Company DUNS079398589
Company NamePRECISION SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840019904889 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019904889]

Moist Heat or Steam Sterilization


[00840019904889]

Moist Heat or Steam Sterilization


[00840019904889]

Moist Heat or Steam Sterilization


[00840019904889]

Moist Heat or Steam Sterilization


[00840019904889]

Moist Heat or Steam Sterilization


[00840019904889]

Moist Heat or Steam Sterilization


[00840019904889]

Moist Heat or Steam Sterilization


[00840019904889]

Moist Heat or Steam Sterilization


[00840019904889]

Moist Heat or Steam Sterilization


[00840019904889]

Moist Heat or Steam Sterilization


[00840019904889]

Moist Heat or Steam Sterilization


[00840019904889]

Moist Heat or Steam Sterilization


[00840019904889]

Moist Heat or Steam Sterilization


[00840019904889]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-19
Device Publish Date2019-04-11

Devices Manufactured by PRECISION SPINE, INC.

00840019975650 - Reform TI Pedicle Screw System2025-05-09 Reduction Driver
00840019975667 - Reform TI Pedicle Screw System2025-05-09 Reduction Driver, Cannulated
00840019975988 - Reform Ti Modular2025-05-09 Ø9.5 x 35mm Modular Bone Screw
00840019975995 - Reform Ti Modular2025-05-09 Ø10.5 x 35mm Modular Bone Screw
00840019976008 - Reform Ti Modular2025-05-09 Ø9.5 x 35mm Modular Bone Screw, Cannulated
00840019976015 - Reform Ti Modular2025-05-09 Ø10.5 x 35mm Modular Bone Screw, Cannulated
00840019976053 - Reform Ti Modular2025-05-08 Ø11.5 x 100mm Modular Bone Screw, Cannulated
00840019976060 - Reform Ti Modular2025-05-08 Ø11.5 x 100mm Modular Bone Screw

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.