TrellOss™-A

GUDID 00840067204825

Slap Hammer

NEXXT SPINE, LLC

General internal orthopaedic fixation system implantation kit
Primary Device ID00840067204825
NIH Device Record Keyada5910d-a545-420c-b25a-d2bd8b561445
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrellOss™-A
Version Model Number330H0004
Company DUNS003489810
Company NameNEXXT SPINE, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone317-436-7801
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS100840067204825 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840067204825]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-25
Device Publish Date2020-03-17

On-Brand Devices [TrellOss™-A]

00840067204467ALIF Distractor Inserter
00840067204849Implant Remover
00840067204832Slap Hammer Adapter
00840067204825Slap Hammer

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.