ASPIRON™ S ACP SYSTEM

GUDID 08800037546203

U&I CORPORATION

Intervertebral-body internal spinal fixation system

Primary Device ID	08800037546203
NIH Device Record Key	c6afcdf4-7a22-42f4-a4fa-ebde09d49b16
Commercial Distribution Status	In Commercial Distribution
Brand Name	ASPIRON™ S ACP SYSTEM
Version Model Number	FC3517VTT
Company DUNS	688811082
Company Name	U&I CORPORATION
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800037546203 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K190053

FDA Product Code

KWQ	Appliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

[08800037546203]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-03-18
Device Publish Date	2021-03-10

On-Brand Devices [ASPIRON™ S ACP SYSTEM]

08800037504302	FC0920
08800037504296	FC0915
08800037504289	FC0914
08800037504272	FC0913
08800037504265	FC0912
08800037504258	FC0911
08800037504241	FC0910
08800037504234	FC9090
08800037504227	FC9080
08800037504210	FC9050
08800037504203	FC9010
08800037504197	FC8010
08800037504180	FC7320
08800037504173	FC7310
08800037504166	FC7300
08800037504159	FC7290
08800037504142	FC7280
08800037504135	FC7270
08800037504128	FC7260
08800037504111	FC7250
08800037504104	FC7020
08800037504098	FCA4111
08800037504081	FCA4107
08800037504074	FCA4103
08800037504067	FCA4099
08800037504050	FCA4095
08800037504043	FCA4091
08800037504036	FCA4087
08800037504029	FCA4083
08800037504012	FCA4079
08800037504005	FCA4075
08800037503992	FCA4071
08800037503985	FCA4067
08800037503978	FCA4063
08800037503961	FCA3081
08800037503954	FCA3078
08800037503947	FCA3075
08800037503930	FCA3072
08800037503923	FCA3069
08800037503916	FCA3066
08800037503909	FCA3063
08800037503893	FCA3060
08800037503886	FCA3057
08800037503879	FCA3054
08800037503862	FCA3051
08800037503855	FCA2055
08800037503848	FCA2053
08800037503831	FCA2051
08800037503824	FCA2049
08800037503817	FCA2047

Trademark Results [ASPIRON]

Mark Image Registration \| Serial	Company Trademark Application Date
ASPIRON 97092002 not registered Live/Pending	Starfire Electronic Technology S.r.l 2021-10-25
ASPIRON 97091999 not registered Live/Pending	Starfire Electronic Technology S.r.l 2021-10-25
ASPIRON 90828724 not registered Live/Pending	SEE PROSPECT LIMITED 2021-07-14
ASPIRON 90828709 not registered Live/Pending	SEE PROSPECT LIMITED 2021-07-14
ASPIRON 86907577 5092902 Live/Registered	Cura Global Health, Inc 2016-02-15
ASPIRON 86713720 not registered Dead/Abandoned	Meril Life Sciences Private Limited 2015-08-04
ASPIRON 78489650 not registered Dead/Abandoned	Aspiron, Inc. 2004-09-26

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