CPX

GUDID 00857915007002

Titanium CPX

A.M. SURGICAL, INC.

External orthopaedic fixation system, single-use, sterile
Primary Device ID00857915007002
NIH Device Record Key2df92f8a-369d-4d8a-afc9-191a604fdda3
Commercial Distribution StatusIn Commercial Distribution
Brand NameCPX
Version Model Number8800-90
Company DUNS160020087
Company NameA.M. SURGICAL, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6319799777
Emailservice@amsurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100857915007002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-25
Device Publish Date2019-03-15

Devices Manufactured by A.M. SURGICAL, INC.

10857915007191 - Secure Screw 40mm2021-02-17 Secure Screw 40mm
00857915007248 - Secure Screw 45mm2021-02-17 Secure Screw 45mm
10857915007214 - Secure Screw 50mm2021-02-17 Secure Screw 50mm
00857915007255 - Secure Screw 55mm2021-02-17 Secure Screw 55mm
10857915007238 - Secure Screw 60mm2021-02-17 Secure Screw 60mm
00857915007262 - Secure Screw Starter Pack 2021-02-17 Secure Screw Starter Pack
10857915007566 - Secure Screw 35mm2021-02-17 Secure Screw 35mm
00857915007606 - PARA CPX2021-01-19 PARA Cross Pin External Fixation Frame and One Tightening Tool

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