510(k) K040212 ยท JDS Nail, Fixation, Bone
TRIGEN INTERTAN
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Feb 20, 2004 |
| Received | Jan 30, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040212
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2022 | Smith & Nephew Orthopaedics GmbH INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left
INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right Open, Classified |
JDS | None listed |
| Nov 2, 2020 | Smith & Nephew, Inc. Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fract Terminated |
JDS | None listed |
| Oct 24, 2017 | Smith & Nephew, Inc. smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL Open, Classified |
JDS | None listed |
| Aug 17, 2014 | Smith & Nephew, Inc. TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL, 125o, REF 71675202, QTY (1), STE Terminated |
JDS | None listed |
| May 20, 2014 | Smith & Nephew Inc TRIGEN INTERTAN NAIL:
(1) REF 71675201, 10 MM X 18 CM, 125 degree,
(2) REF 71675202, 11.5 MM X 18 CM, 125 degree,
(3) REF 71675203, 13 MM X 18 CM, 125 degree,
(4) REF 71675204, 10 MM X 20 CM, 125 Terminated |
JDS | None listed |
| May 20, 2014 | Smith & Nephew Inc TRIGEN INTERTAN 1.5 NAIL:
(1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT,
(2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT,
(3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT,
(4) REF 71 Terminated |
JDS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.