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
351-375 of 376
Cleared Feb 18, 2000
SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL...
K994143 · JDW
Orthopedic · 72d
Cleared Jan 28, 2000
BIOLOX ALUMINA CERAMIC FEMORAL HEAD
K991162 · LZO
Orthopedic · 296d
Cleared Dec 20, 1999
SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM
K993289 · KTT
Orthopedic · 80d
Cleared Dec 09, 1999
SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)
K993106 · HRS
Orthopedic · 83d
Cleared Nov 18, 1999
RCI FIXATION SCREWS (WITH ASSORTED SIZES)
K992945 · HWC
Orthopedic · 78d
Cleared Oct 22, 1999
REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS
K991026 · LPH
Orthopedic · 207d
Cleared Aug 06, 1999
HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA)...
K990666 · MEH
Orthopedic · 157d
Cleared Jul 12, 1999
SYNERGY POROUS SIZE 8 HIP STEM
K991485 · LPH
Orthopedic · 75d
Cleared Mar 12, 1999
SYNERGY CEMENTED HIP STEM
K990369 · JDI
Orthopedic · 32d
Cleared Feb 24, 1999
ECHELON HIP STEM
K983834 · LPH
Orthopedic · 117d
Cleared Jan 28, 1999
BIOABSORBABLE INTERFERENCE SCREWS
K984320 · HWC
Orthopedic · 56d
Cleared Dec 04, 1998
INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP
K983942 · JDS
Orthopedic · 29d
Cleared Jul 17, 1998
BIOLOX ALUMINA CERAMIC FEMORAL HEAD
K981847 · LZO
Orthopedic · 52d
Cleared Jul 09, 1998
TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW
K981529 · JDS
Orthopedic · 71d
Cleared May 20, 1998
RCI FIXATION SCREWS
K980841 · HWC
Orthopedic · 77d
Cleared May 20, 1998
DYONICS INTELIJET INFLOW/OUTFLOW CANNULA
K981156 · HRX
Orthopedic · 50d
Cleared Aug 12, 1997
DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
K970511 · HRX
Orthopedic · 182d
Cleared Jun 27, 1997
LIMITED REUSE ENDOSCOPIC BLADES
K971676 · HRX
Orthopedic · 51d
Cleared Jun 13, 1997
VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS
K971253 · HRX
Orthopedic · 71d
Cleared Feb 27, 1997
9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW
K965073 · HWC
Orthopedic · 70d
Cleared Jun 20, 1995
SIMMONS PLATING SYSTEM BOLT AND SCREW
K930353 · MNH
Orthopedic · 880d
Cleared Oct 19, 1994
AIMS CANNULATED ACL SCREW
K943539 · HWC
Orthopedic · 89d
Cleared Sep 28, 1994
CURVED ROTATABLE DISPOSABLE ARTHROSCOPIC SURGERY BLADES
K941036 · HRX
Orthopedic · 205d
Cleared Jun 29, 1994
SMITH AND NEPHEW SPINE DEFLECTING FORCEPS
K940222 · HRX
Orthopedic · 162d
Cleared Mar 29, 1994
MOD. PERCUTANEOUS ARTHROSCOPIC MICRO DISCECTOMY
K922519 · HRX
Orthopedic · 685d

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