510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Smith & Nephew Richards, Inc.

Memphis, TN, US

Smith & Nephew Richards, Inc. appears in FDA device records in Memphis, TN. FDA records list 87 510(k) clearances between and , 6 PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
87
PMA records
6
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 87

FDA records hold 87 510(k) clearances for Smith & Nephew Richards, Inc. between 1990 and 1997. The busiest year on record is 1995, with 27. The most recent is 1997, with 3.

Clearances by year, as a table
510(k) clearance decisions for Smith & Nephew Richards, Inc., by decision year
YearClearances
19902
19917
19928
199310
199418
199527
199612
19973
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K965224EMPOWER ANTERIOR DIRECT SCREWSKWPSubstantially Equivalent
K963509GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRONLPHSubstantially Equivalent
K960444FINN ROD TO ROD CONNECTORKWPSubstantially Equivalent
K964163TRIMAX NAIL SYSTEMHSBSubstantially Equivalent
K962557GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENTJWHSubstantially Equivalent for Some Indications
K963486REVISION HIP SYSTEMJDISubstantially Equivalent
K962541REFLECTION ACETABULAR REINFORCEMENT RINGSJDJSubstantially Equivalent
K962808ILIZAROV EXTERNAL FIXATION SYSTEMKTTSubstantially Equivalent
K962137GENESIS II CONSTRAINED SYSTEMJWHSubstantially Equivalent
K955767COFIED MODULAR SHOULDER SYSTEMKWSSubstantially Equivalent for Some Indications
K960094REFLECTION DUAL DIMENSION SHELLMBLSubstantially Equivalent
K954696ROGOZINSKI THORACOLUMBAR SPINAL RODKWPSubstantially Equivalent for Some Indications
K953274GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEMJWHSubstantially Equivalent for Some Indications
K954909PROFIX POSTERIOR-STABILIZED KNEE SYSTEMJWHSubstantially Equivalent for Some Indications
K955552EXPRESSAIRE TORUNIQUET SYSTEMKCYSubstantially Equivalent
K954491HYDROCELL NASAL AND SINUS PACKSEMXSubstantially Equivalent
K954712INTRAMEDULLARY HIP SCREW (MODIFICATION)KTTSubstantially Equivalent
K953397HEX-FIX FIELD FIXATORLXTSubstantially Equivalent
K952697TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEMHWCSubstantially Equivalent
K952271GENESIS CONSTRAINED SYSTEM (GCS)JWHSubstantially Equivalent
K950865ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL) CONNECTOR FOR USE WITH THE SIMMONS PLATING SYSTEM BOLTMNHSubstantially Equivalent for Some Indications
K951987GENESIS II TOTAL KNEE SYSTEMJWHSubstantially Equivalent
K950093AMD SYSTEM WORKING CHANNEL SCOPE AND ACCESSORIESHRXSubstantially Equivalent
K946088GENESIS POSTERIOR STABILIZED (P/S) KNEE SYSTEMJWHSubstantially Equivalent
K953096ESSENTIAL SHAVER SYSTEMEQJSubstantially Equivalent
K951389REUNION BONE SCREW SYSTEMHWCSubstantially Equivalent for Some Indications
K946236PROFIX CONFORMING PLUS TIBIAL INSERTKWHSubstantially Equivalent
K952549RICHARDS TORPETASubstantially Equivalent
K952481RICHARDS PORPETBSubstantially Equivalent
K934590IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTSHWCSubstantially Equivalent
K930298ROGOZINSKI SPINAL ROD SYSTEM SCREWMNHSubstantially Equivalent
K952207NASAL SEPTAL SPLINTLYASubstantially Equivalent
K950394TIBIA-TALUS-CALCANEUS NAILHSBSubstantially Equivalent
K951803ROSSITER SINUS STENTKAMSubstantially Equivalent
K951066RAINS FRONTAL SINUS STENTKAMSubstantially Equivalent
K935235ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERYGCMSubstantially Equivalent
K950927HAPEX MALLEABLE TORPETASubstantially Equivalent
K950984HAPES MALLEABLE INCUS STAPESETBSubstantially Equivalent
K950887HAPEX INCUSETBSubstantially Equivalent
K950886HAPEX PORPETBSubstantially Equivalent
K950885HAPEX MALLEABLE PORPETBSubstantially Equivalent
K933958RICHARDS TOTAL KNEE SYSTEMJWHSubstantially Equivalent for Some Indications
K943523ANTERIOR CERVIAL PLATING SYSTEMKWQSubstantially Equivalent for Some Indications
K935921ZIRCONIA CERAMIC FEMORAL HEADLZOSubstantially Equivalent for Some Indications
K942760PNEUMATIC WIRE TENSIONERHSZSubstantially Equivalent
K931131THE RICHARDS WRISTJWJSubstantially Equivalent for Some Indications
K936233PELVIC RADIUS PLATEHRSSubstantially Equivalent
K934733STIMULATING SURGICAL INSTRUMENTSETNSubstantially Equivalent
K941264RICHARD ROD LENS LARYNGOSCOPEEOQSubstantially Equivalent
K930480VARIABLE ANGULAR HOLD BONE PLATE SYSTEMHRSSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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Data as of , FDA export datePage updated Source: openFDA, public domain