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
376 devices
301-325 of 376
Cleared Jul 14, 2003
EXTERNAL FIXATION SYSTEMS
K031181 · KTT
Orthopedic · 90d
Cleared Jul 01, 2003
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
K031685 · HWC
Orthopedic · 29d
Cleared Jun 18, 2003
INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY
K031605 · HRX
Orthopedic · 27d
Cleared May 27, 2003
GENESIS II TOTAL KNEE SYSTEM
K030612 · MBH
Orthopedic · 90d
Cleared May 22, 2003
SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM
K030623 · MBH
Orthopedic · 84d
Cleared May 01, 2003
SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM
K031162 · JDQ
Orthopedic · 17d
Cleared Mar 04, 2003
MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS
K030344 · KWS
Orthopedic · 29d
Cleared Feb 26, 2003
SMITH & NEPHEW FEMORAL HEADS
K024340 · JDI
Orthopedic · 61d
Cleared Feb 25, 2003
JAX
K010555 · MQV
Orthopedic · 729d
Cleared Feb 25, 2003
UNICONDYLAR FEMORAL COMPONENT
K030301 · JWH
Orthopedic · 27d
Cleared Feb 20, 2003
DYONICS POWER CONTROL UNIT
K030196 · HRX
Orthopedic · 30d
Cleared Feb 05, 2003
JET-X HA COATED HALF PINS
K023921 · JDW
Orthopedic · 72d
Cleared Jan 23, 2003
SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM
K023743 · KWY
Orthopedic · 77d
Cleared Dec 19, 2002
REFLECTION CONSTRAINED LINER
K021803 · KWZ
Orthopedic · 199d
Cleared Nov 19, 2002
BIOBUCK CEMENT RESTRICTOR
K023680 · LZN
Orthopedic · 18d
Cleared Nov 07, 2002
SURETAC III, MODELS 7209900, 7209901
K023417 · JDR
Orthopedic · 27d
Cleared Oct 25, 2002
ECHELON POROUS PLUS HA HIP STEMS
K023302 · MEH
Orthopedic · 22d
Cleared Oct 09, 2002
SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II
K020948 · JDR
Orthopedic · 198d
Cleared Oct 09, 2002
JET-X TIN COATED HALF PINS
K023134 · JDW
Orthopedic · 19d
Cleared Oct 04, 2002
MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T
K023021 · HWC
Orthopedic · 23d
Cleared Oct 02, 2002
SMITH & NEPHEW HIP SYSTEM
K022902 · LPH
Orthopedic · 29d
Cleared Oct 02, 2002
TOTAL HIP FEMORAL HEADS AND LINERS
K022958 · JDI
Orthopedic · 26d
Cleared Sep 23, 2002
ORTHOGUARD AB ANTIMICROBIAL SLEEVE
K022676 · JEC
Orthopedic · 42d
Cleared Aug 28, 2002
REFLECTION MODIFIED ACETABULAR SHELLS
K022556 · LPH
Orthopedic · 26d
Cleared Aug 19, 2002
TOTAL KNEE FEMORAL COMPONENT
K022010 · JWH
Orthopedic · 61d

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