Panels › Orthopedic › Product code HTY · Class 2
Pin, Fixation, Smooth
Regulation 888.3040
3510(k)s in 12 months (206 all time)
1recalls in 12 months (32 all time)
27recalls that name a 510(k)
Top companies in HTY
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Biomet, Inc. | 0 | 14 |
| Arthrex, Inc. | 13 | 0 |
| Biomet, Inc. | 5 | 2 |
| OSSIO , Ltd. | 6 | 0 |
| Synthes (Usa) | 5 | 0 |
| Bioretec, Ltd. | 4 | 0 |
| The Huxley Instrument Corp. | 4 | 0 |
| OrthoPediatrics Corp. | 4 | 0 |
| Paragon 28 | 3 | 1 |
| Smith & Nephew, Inc. | 1 | 3 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 2, 1997 | K970733 | SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM Synthes (Usa) | HTY |
| Mar 25, 1997 | K970036 | FIXATION PIN OR ROD United States Surgical, A Division of Tyco Healthc | HTY |
| Mar 13, 1997 | K970013 | BIORIGID NAIL TIBIA Aap GmbH and Co. Betriebs KG, DE | HTY |
| Dec 9, 1996 | K964500 | ACUMED TENSION BAND PIN Acu Med, Inc. | HTY |
| Nov 25, 1996 | K964087 | BLOCK STOP WIRES Ferguson Medical | HTY |
| Oct 30, 1996 | K963367 | RMS K-WIRE Rms Div. | HTY |
| Sep 23, 1996 | K961522 | KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN Synvasive Technology, Inc. | HTY |
| May 17, 1996 | K960642 | NANCY NAIL Landos, Inc. | HTY |
| Apr 9, 1996 | K960483 | STEINMAN PIN American Medical Specialties, Inc. | HTY |
| Apr 9, 1996 | K960482 | K-WIRE American Medical Specialties, Inc. | HTY |
| Mar 27, 1996 | K960385 | STERILE KIRSCHNER WIRES AND STEINMANN PINS Depuy, Inc. | HTY |
| Feb 15, 1996 | K955806 | HOWMEDICA BIOABSORBABLE PIN Howmedica, Inc. | HTY |
| Dec 8, 1995 | K954543 | GO UNIVERSALK-WIRE FLUTED DRILL Genesis Orthopedics, Inc. | HTY |
| Oct 31, 1995 | K953194 | LACTOSORB BONE PIN Biomet, Inc. | HTY |
| Oct 26, 1995 | K954001 | SPETZLER PIN Howmedica Corp. | HTY |
| Jul 6, 1995 | K943856 | FIXATION PINS/WIRES Acu Med, Inc. | HTY |
| Apr 14, 1995 | K945639 | SPETZLER PIN Howmedica Corp. | HTY |
| Nov 14, 1994 | K940673 | J.B.S. SELF-TAPPING THREADED PIN J.B.S., S.A. | HTY |
| Nov 14, 1994 | K940669 | J.B.S. B.A.C. PIN J.B.S., S.A. | HTY |
| Nov 14, 1994 | K940666 | JBS SMOOTH FIXATION PIN J.B.S., S.A. | HTY |
| Oct 3, 1994 | K941434 | K-WIRES AND STEINMANN PINS Omega Surgical Instruments, Inc. | HTY |
| Jul 19, 1994 | K925098 | BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE Bioscience, Inc. | HTY |
| Jun 28, 1994 | K931836 | ACUFEX SMOOTH AND THREADED PINS Acufex Microsurgical, Inc. | HTY |
| May 12, 1994 | K931697 | FIXATION PIN Orthologic Corp. | HTY |
| Mar 29, 1994 | K930969 | BAUMER PINS Baumer Ortopedia , Ltd., BR | HTY |
| Mar 1, 1994 | K932348 | ORTHOPEDIC SMOOTH PIN FIXATION Osteomed Corp. | HTY |
| Feb 22, 1994 | K940109 | TAVA K-WIRE Tava Surgical Instruments | HTY |
| Jul 9, 1993 | K922766 | ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION Acufex Microsurgical, Inc. | HTY |
| Mar 16, 1993 | K925301 | OTI ORTHOPEDIC FASTENER SYSTEM Osteo Technology, Inc. | HTY |
| Jul 23, 1992 | K922194 | OSTEO STEINMANN PIN Osteo AG | HTY |
| Jul 23, 1992 | K922193 | OSTEO KIRSCHNER WIRE Osteo AG | HTY |
| Sep 23, 1991 | K911375 | G-PIN Dr.M.A.Galluzzo | HTY |
| Apr 12, 1991 | K911505 | FIXATION WIRE Simpex, Inc. | HTY |
| Apr 12, 1991 | K911452 | FIXATION PIN Simpex, Inc. | HTY |
| Dec 11, 1990 | K905345 | K-WIRE O'Tec Corp. | HTY |
| Dec 11, 1990 | K905341 | RUSH PIN O'Tec Corp. | HTY |
| Dec 11, 1990 | K905337 | STEINMAN PIN O'Tec Corp. | HTY |
| Jul 30, 1990 | K903265 | STEINMAN PIN Onyx Medical Corp. | HTY |
| Jul 30, 1990 | K903264 | K-WIRE Onyx Medical Corp. | HTY |
| Jun 5, 1990 | K901273 | L.M.S. SELF-DETACHABLE BROACH WITH STOP Med-Tek Corp. | HTY |
| Nov 3, 1989 | K890902 | BIOFIX* BIODEGRADABLE FIXATION ROD Davis & Geck, Inc. | HTY |
| Sep 13, 1989 | K895079 | ACE BEADED K-WIRES ACE OLIVE WIRES Buckman Co., Inc. | HTY |
| Jan 7, 1988 | K874913 | ORTHOMET PIN SYSTEM Orthomet, Inc. | HTY |
| Aug 7, 1987 | K872842 | PIN, HIP, KNOWLES Military Engineering, Inc. | HTY |
| Jul 9, 1987 | K864912 | PDS (POLYDIOXANON) ABSORBABLE PIN Johnson & Johnson Professionals, Inc. | HTY |
| Oct 20, 1986 | K863734 | STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINS Micro-Aire Surgical Instruments, Inc. | HTY |
| Sep 3, 1986 | K863119 | CANNULATED LAG SCREWS Downs Surgical , Ltd., GB | HTY |
| Mar 7, 1986 | K860590 | ACE UNILATERAL FIXATOR Buckman Co., Inc. | HTY |
| Jun 28, 1985 | K852563 | PIN SET, BONE RUSH, 7-1/4 THRU 18-1/2 INCHES LONG The Huxley Instrument Corp. | HTY |
| Jun 28, 1985 | K852562 | PIN SET, BONE, RUSH, 4 THRU 10 1/2 INCHES LONG The Huxley Instrument Corp. | HTY |
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