TPLC - Total Product Life Cycle

show TPLC since

Device	prosthesis, shoulder, semi-constrained, metal/polymer cemented
Regulation Description	Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Product Code	KWS
Regulation Number	888.3660
Device Class	2

Premarket Reviews
Manufacturer	Decision
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	2
BIOMET, INC.
	SUBSTANTIALLY EQUIVALENT	1
CATALYST ORTHOSCIENCE, INC.
	SUBSTANTIALLY EQUIVALENT	2
DEPUY LNC.
	SUBSTANTIALLY EQUIVALENT	1
ENCORE MEDICAL, LP
	SUBSTANTIALLY EQUIVALENT	3
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
LIMACORPORATE
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S .A.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	4
STRYKER CORPORATION (TORNIER, INC.)
	SUBSTANTIALLY EQUIVALENT	2
STRYKER GMBH
	SUBSTANTIALLY EQUIVALENT	2
TORNIER S.A.S.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	1