Company · US

Rotation Medical, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2014. Name variants (Inc, Corp, punctuation) are merged.

5510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
FTM	Mesh, Surgical	2
GDW	Staple, Implantable	1
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	1
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	1

Decided	510(k)	Device and applicant	Code
Mar 26, 2014	K140300	COLLAGEN TENDON SHEET-DDI (CTS-DDI) Rotation Medical, Inc.	OWY
Aug 29, 2013	K131635	ROTATION MEDICAL BONE STAPLE (RMB STAPLE) Rotation Medical, Inc.	MBI
Jul 12, 2013	K131637	ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE) Rotation Medical, Inc.	GDW
Jan 8, 2013	K122048	COLLAGEN TENDON SHEET-D Rotation Medical, Inc.	FTM
Dec 22, 2011	K112423	COLLAGEN TENDON SHEET Rotation Medical, Inc.	FTM

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.