Medical Device Manufacturer · US , Shelton , CO

Emerge Medical - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2010
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Emerge Medical Orthopedic ✕
10 devices
1-10 of 10
Cleared Oct 02, 2014
EMERGE MEDICAL IM NAIL SYSTEM
K141347 · HSB
Orthopedic · 133d
Cleared Mar 13, 2014
EMERGE MEDICAL DISTAL RADIUS SET
K140107 · HRS
Orthopedic · 57d
Cleared Mar 12, 2014
EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM
K140098 · HRS
Orthopedic · 57d
Cleared Mar 12, 2014
EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEM
K140119 · HRS
Orthopedic · 55d
Cleared Feb 26, 2014
EMERGE MEDICAL BONE PLATE SYSTEM
K133536 · HRS
Orthopedic · 100d
Cleared Jan 28, 2014
EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SYSTEM
K133541 · HRS
Orthopedic · 71d
Cleared Jan 08, 2014
EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM
K133452 · HRS
Orthopedic · 57d
Cleared Jul 03, 2013
EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM
K131480 · HRS
Orthopedic · 42d
Cleared Dec 10, 2012
EMERGE MEDICAL SOLID BONE SCREWS
K122489 · HWC
Orthopedic · 117d
Cleared Nov 23, 2010
EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM
K102343 · HWC
Orthopedic · 98d
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