Unity Tool Inc

FDA Filings

This page includes the latest FDA filings for Unity Tool Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 2133687
• FEI Number: 3000206619
• Name: UNITY TOOL, INC.
• Owner & Operator: UNITY TOOL, INC.
• Contact Address: 11660 TROY LN. --; Maple Grove MN 55369 US
• Official Correspondent:
  • MICHAEL R VAN ESSEN
  • 1-763-4289888-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 11660 TROY LN ; Osseo, MN 55369 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K183184 | MAX UNITY TOOL, INC.	Max	2019-09-25
PMN K182114 | MAX UNITY TOOL, INC.	MAX	2019-09-25
PMN K160076 | MAX UNITY TOOL, INC.	FlareHawk Interbody Fusion System	2019-01-04
PMN K133514 | MAX UNITY TOOL, INC.	FlareHawk Interbody Fusion System	2019-01-04
PMN K133291 | NKB UNITY TOOL, INC.	ST360	2014-12-30
PMN K133291 | MNI UNITY TOOL, INC.	ST360	2014-12-30
PMN K133291 | MNH UNITY TOOL, INC.	ST360	2014-12-30
PMN K133291 | KWP UNITY TOOL, INC.	ST360	2014-12-30
HWB UNITY TOOL, INC.	Silhouette	2014-12-30
HTJ UNITY TOOL, INC.	Symmetry	2014-04-03
HTJ UNITY TOOL, INC.	Puros Family (Allogaft)	2014-04-03
HTJ UNITY TOOL, INC.	Dynesys	2014-04-03
HTJ UNITY TOOL, INC.	BAC/C	2014-04-03
GAD UNITY TOOL, INC.	Mergence	2014-04-03
FZO UNITY TOOL, INC.	Symmetry	2014-04-03
FZO UNITY TOOL, INC.	Puros Family ( Allogaft)	2014-04-03
PMN K131980 | NKB UNITY TOOL, INC.	Sequoia (Gen ll)	2013-12-20
PMN K131980 | NKB UNITY TOOL, INC.	Pathfinder NXT	2013-12-20
PMN K131980 | MNI UNITY TOOL, INC.	Sequoia (Gen ll)	2013-12-20
PMN K131980 | MNI UNITY TOOL, INC.	Pathfinder NXT	2013-12-20
PMN K131980 | MNH UNITY TOOL, INC.	Sequoia (Gen ll)	2013-12-20
PMN K131980 | MNH UNITY TOOL, INC.	Pathfinder NXT	2013-12-20
HWX UNITY TOOL, INC.	Trinica ALP	2013-12-20
HWX UNITY TOOL, INC.	ST360	2013-12-20
HWX UNITY TOOL, INC.	BP/Lordotic	2013-12-20
GFC UNITY TOOL, INC.	ST360	2013-12-20
PMN K100845 | NKB UNITY TOOL, INC.	ST360	2013-03-19
PMN K100845 | MNI UNITY TOOL, INC.	ST360	2013-03-19
PMN K100845 | MNH UNITY TOOL, INC.	ST360	2013-03-19
HXX UNITY TOOL, INC.	Dynesys	2013-03-19
HWT UNITY TOOL, INC.	Trial Eccenter	2013-01-22
HTO UNITY TOOL, INC.	BP/Lordotic	2013-01-22
HTO UNITY TOOL, INC.	32mm Reamer for Glenoid	2013-01-22
HTO UNITY TOOL, INC.	28mm Reamer for Gleniod	2013-01-22
FZX UNITY TOOL, INC.	Zimmer MIS	2013-01-22
FZX UNITY TOOL, INC.	ST360	2013-01-22
FZX UNITY TOOL, INC.	InViSia	2013-01-22
FZX UNITY TOOL, INC.	ARAS	2013-01-22
LXH UNITY TOOL, INC.	Stem Holder Size 8 for Pr	2012-12-26
LXH UNITY TOOL, INC.	Stem Holder Size 6 for Pr	2012-12-26
LXH UNITY TOOL, INC.	Stem Holder Size 14 for Pr	2012-12-26
LXH UNITY TOOL, INC.	Stem Holder Size 12 for Pr	2012-12-26
LXH UNITY TOOL, INC.	Stem Holder Size 10 for Pr	2012-12-26
LXH UNITY TOOL, INC.	Silhouette	2012-12-26
LXH UNITY TOOL, INC.	ST360	2012-12-26
LXH UNITY TOOL, INC.	Pangea Threaded Remobiliz	2012-12-26
LXH UNITY TOOL, INC.	Manual instruments intended for spinal surgery	2012-12-26
LXH UNITY TOOL, INC.	MIS Threaded Remobilizer	2012-12-26
LXH UNITY TOOL, INC.	Compressor/Distractor-STA	2012-12-26
LXH UNITY TOOL, INC.	Compressor/Distractor-LON	2012-12-26
PMN P040001 | NQO UNITY TOOL, INC.	X-STOP Kyphon	2012-11-07
KOA UNITY TOOL, INC.	Rossello Cavernotome Set	2012-11-07
KOA UNITY TOOL, INC.	Brooks Dilator	2012-11-07

Related Finance Registrations

NCAGE Code	35SU7	UNITY TOOL INC
CAGE Code	35SU7	UNITY TOOL INC
DUNS	087252672	UNITY TOOL, INC