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510(k) K994143 · JDW Pin, Fixation, Threaded

SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]

Applicant	Smith & Nephew, Inc., Memphis TN, US
Decision	Substantially Equivalent, Feb 18, 2000
Received	Dec 8, 1999
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K994143

Date	Firm and product	Code	Linked 510(k)
Jun 6, 2012	Smith & Nephew Inc JET-X(R) BAR 5 MM X 45 MM BAR SHORT HALF PIN TI-6AL-4V, REF 71055451, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device. Terminated	JDW	None listed
Jun 6, 2012	Smith & Nephew Inc JET-X(R) 6 MM X 20 MM SHORT HALF PIN TI-6AL-4V, REF 71056208, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device. Terminated	JDW	None listed
Jun 6, 2012	Smith & Nephew Inc JET-X(R) 6 MM X 25 MM SHORT HALF PIN TI-6AL-4V, REF 71056258, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device. Terminated	JDW	None listed
Jun 6, 2012	Smith & Nephew Inc JET-X(R) 6 MM X 30 MM SHORT HALF PIN TI-6AL-4V, REF 71056308, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device. Terminated	JDW	None listed
Jun 6, 2012	Smith & Nephew Inc JET-X(R) 6 MM X 35 MM SHORT HALF PIN TI-6AL-4V, REF 71056358, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device. Terminated	JDW	None listed
Jun 6, 2012	Smith & Nephew Inc JET-X(R) 6 MM X 40 MM SHORT HALF PIN TI-6AL-4V, REF 71056408, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device. Terminated	JDW	None listed
Jun 6, 2012	Smith & Nephew Inc JET-X(R) 6 MM X 45 MM SHORT HALF PIN TI-6AL-4V, REF 71056458, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device. Terminated	JDW	None listed
Jun 6, 2012	Smith & Nephew Inc JET-X(R) 6 MM X 50 MM SHORT HALF PIN TI-6AL-4V, REF 71056508, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device. Terminated	JDW	None listed
Jun 6, 2012	Smith & Nephew Inc JET-X(R) 6 MM X 55 MM SHORT HALF PIN TI-6AL-4V, REF 71056558, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device. Terminated	JDW	None listed
Jun 6, 2012	Smith & Nephew Inc JET-X(R) 6 MM X 60 MM SHORT HALF PIN TI-6AL-4V, REF 71056608, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device. Terminated	JDW	None listed
Jun 6, 2012	Smith & Nephew Inc JET-X(R) 6 MM X 65 MM SHORT HALF PIN TI-6AL-4V, REF 71056658, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device. Terminated	JDW	None listed
Jun 6, 2012	Smith & Nephew Inc JET-X(R) 6 MM X 70 MM SHORT HALF PIN TI-6AL-4V, REF 71056708, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device. Terminated	JDW	None listed
Jun 6, 2012	Smith & Nephew Inc JET-X(R) 5 MM X 20 MM SHORT HALF PIN TI-6AL-4V, REF 71055201, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device. Terminated	JDW	None listed
Jun 6, 2012	Smith & Nephew Inc JET-X(R) 5 MM X 25 MM SHORT HALF PIN TI-6AL-4V, REF 71055251, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device. Terminated	JDW	None listed
Jun 6, 2012	Smith & Nephew Inc JET-X(R) 5 MM X 30 MM SHORT HALF PIN TI-6AL-4V, REF 71055301, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device. Terminated	JDW	None listed
Jun 6, 2012	Smith & Nephew Inc JET-X(R) 5 MM X 35 MM SHORT HALF PIN TI-6AL-4V, REF 71055351, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device. Terminated	JDW	None listed
Jun 6, 2012	Smith & Nephew Inc JET-X(R) 5 MM X 40 MM SHORT HALF PIN TI-6AL-4V, REF 71055401, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device. Terminated	JDW	None listed
Jun 6, 2012	Smith & Nephew Inc JET-X(R) 5 MM X 55 MM SHORT HALF PIN TI-6AL-4V, REF 71055551, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device. Terminated	JDW	None listed
Sep 15, 2009	Smith & Nephew Inc Smith & Nephew Orthopaedics PIP (proximal Interphalangeal) FIXATION HINGE KIT, REF 101638, for external fixation of finger joint. Terminated	JDW	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.