Medical Device Manufacturer · US , Andover , MA

Smith & Nephew Inc., Endoscopy Div.

10 submissions · 10 cleared · Since 2007
10
Total
10
Cleared
0
Denied

Smith & Nephew Inc., Endoscopy Div. — FDA 510(k) Submissions

Smith & Nephew Inc., Endoscopy Div. has submitted 10 FDA 510(k) premarket notifications since 2007, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, Fastener, Fixation, Nondegradable, Soft Tissue, Plate, Fixation, Bone, Screw, Fixation, Bone, Orthopedic Stereotaxic Instrument . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
REGENETEN? Bioinductive Implant
K242631 · OWY Mesh, Surgical, Collagen,... · Orthopedic
Nov 2024 84d
ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM
K111843 · OLO Orthopedic Stereotaxic... · Orthopedic
Nov 2011 138d
SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY
K102544 · KCT Sterilization Wrap... · General Hospital
Jan 2011 124d
SMITH & NEPHEW INSTRUMENT TRAYS
K092551 · KCT Sterilization Wrap... · General Hospital
Sep 2010 390d
SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR
K100159 · MBI Fastener, Fixation,... · Orthopedic
Apr 2010 89d
BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM
K093943 · MBI Fastener, Fixation,... · Orthopedic
Mar 2010 73d
SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR
K093897 · MBI Fastener, Fixation,... · Orthopedic
Mar 2010 76d
SMITH & NEPHEW INSTRUMENT TRAYS
K073551 · KCT Sterilization Wrap... · General Hospital
May 2008 155d
PLLA, HA SCREW
K080358 · HWC Screw, Fixation, Bone · Orthopedic
Apr 2008 72d
PLC SUTURE ANCHOR
K063726 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2007 81d
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