TPLC - Total Product Life Cycle

show TPLC since

Device	neurological stereotaxic instrument
Regulation Description	Stereotaxic instrument.
Product Code	HAW
Regulation Number	882.4560
Device Class	2

Premarket Reviews
Manufacturer	Decision
7D SURGICAL ULC
	SUBSTANTIALLY EQUIVALENT	1
BAYER MEDICAL CARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
BRAIN NAVI BIOTECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BRAINLAB AG
	SUBSTANTIALLY EQUIVALENT	8
CLARONAV
	SUBSTANTIALLY EQUIVALENT	1
CLEARPOINT NEURO, INC.
	SUBSTANTIALLY EQUIVALENT	10
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
	SUBSTANTIALLY EQUIVALENT	1
INTRAVENT MEDICAL PARTNERS
	SUBSTANTIALLY EQUIVALENT	1
INTRAVENT MEDICAL PARTNERS, LP
	SUBSTANTIALLY EQUIVALENT	1
KOH YOUNG TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
LOCALITE GMBH
	SUBSTANTIALLY EQUIVALENT	1
MEDIVIS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTECH S.A.S
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC NAVIGATION
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC NAVIGATION, INC.
	SUBSTANTIALLY EQUIVALENT	4
NAVINETICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
PAJUNK GMBH MEDIZINTECHNOLOGIE
	SUBSTANTIALLY EQUIVALENT	2
PHASOR HEALTH, LLC
	SUBSTANTIALLY EQUIVALENT	1
SINOVATION (BEIJING) MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
THERATAXIS, LLC
	SUBSTANTIALLY EQUIVALENT	1
TONICA ELEKTRONIK A/S
	SUBSTANTIALLY EQUIVALENT	1
ZETA SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
ZETA SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3