Medical Device Manufacturer · US , Mchenry , IL

Smith & Nephew, Inc. - FDA 510(k) Cleared Devices

530 submissions · 517 cleared · Since 1980
530
Total
517
Cleared
0
Denied
530 devices
251-275 of 530
Cleared Oct 29, 2008
PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1
K082267 · HAW
Neurology · 79d
Cleared Sep 17, 2008
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS
K082516 · HWC
Orthopedic · 15d
Cleared Sep 05, 2008
SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM
K081016 · PHX
Orthopedic · 149d
Cleared Sep 05, 2008
RENASYS EZ
K082426 · OMP
General & Plastic Surgery · 14d
Cleared Aug 26, 2008
2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S
K081511 · MBI
Orthopedic · 89d
Cleared Aug 21, 2008
SMITH & NEPHEW OXINIUM DH FEMORAL HEADS
K081566 · LPH
Orthopedic · 78d
Cleared Jul 31, 2008
MDF REVISION HIP SYSTEM
K081124 · MEH
Orthopedic · 101d
Cleared Jul 24, 2008
MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT
K081351 · HSX
Orthopedic · 71d
Cleared Jul 23, 2008
LEGION HINGE KNEE SYSTEM
K081111 · KRO
Orthopedic · 96d
Cleared Jul 18, 2008
PIGALILEO 4TH GENERATION SYSTEM
K080875 · HAW
Neurology · 109d
Cleared Jun 19, 2008
SMITH & NEPHEW CDS SYSTEM
K081491 · JAA
Radiology · 22d
Cleared Jun 18, 2008
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING...
K081106 · HRS
Orthopedic · 61d
Cleared Jun 09, 2008
SL-PLUS STANDARD AND LATERAL HIP STEMS
K072852 · LZO
Orthopedic · 249d
Cleared May 15, 2008
ECHELON TITANIUM HIP SYSTEM
K072817 · LPH
Orthopedic · 226d
Cleared May 08, 2008
SMITH & NEPHEW MIS HIP STEM WITH STIKTITE
K080625 · LPH
Orthopedic · 64d
Cleared Apr 10, 2008
INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW
K080434 · JDO
Orthopedic · 51d
Cleared Mar 07, 2008
JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE
K072212 · KTT
Orthopedic · 211d
Cleared Mar 04, 2008
TWINFIX PK FP SUTURE ANCHOR
K073509 · HWC
Orthopedic · 82d
Cleared Feb 22, 2008
SMITH & NEPHEW INTRADISCAL CATHETER SYSTEM
K073466 · GEI
General & Plastic Surgery · 74d
Cleared Jan 10, 2008
SMITH & NEPHEW MIS HIP STEM
K072417 · LPH
Orthopedic · 135d
Cleared Dec 20, 2007
JOURNEY UNICONDYLAR FEMORAL IMPLANT
K073175 · HSX
Orthopedic · 37d
Cleared Dec 20, 2007
LEGION POROUS PRIMARY
K073325 · MBH
Orthopedic · 23d
Cleared Dec 06, 2007
LEGION STEM WITH HOLES
K072531 · JWH
Orthopedic · 90d
Cleared Nov 20, 2007
TC-PLUS PRIMARY KNEE SYSTEM
K072858 · JWH
Orthopedic · 46d
Cleared Nov 19, 2007
PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS
K072818 · HRS
Orthopedic · 48d

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