Panels › Orthopedic › Product code KWP · Class 2
Appliance, Fixation, Spinal Interlaminal
Regulation 888.3050
0510(k)s in 12 months (430 all time)
0recalls in 12 months (68 all time)
65recalls that name a 510(k)
Top companies in KWP
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 54 | 12 |
| Synthes (Usa) | 17 | 0 |
| Zimmer, Inc. | 7 | 10 |
| Danek Medical, Inc. | 16 | 0 |
| K2m | 12 | 3 |
| Acromed Corp. | 14 | 0 |
| Seaspine, Inc. | 3 | 10 |
| Sofamor Danek USA,Inc. | 13 | 0 |
| Depuy, Inc. | 11 | 0 |
| Alphatec Spine, Inc. | 4 | 6 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 31, 1992 | K921090 | ISOLA(R) TRANSVERSE ROD DUAL CONNECTOR Acromed Corp. | KWP |
| Dec 31, 1992 | K920392 | ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION Acromed Corp. | KWP |
| Dec 23, 1992 | K922238 | LEAPLAZA FRAME Spintech, Inc. | KWP |
| Nov 16, 1992 | K922520 | MODIFIED TSRH CENTRAL POST HOOKS Sofamor Danek Mfg., Inc. | KWP |
| Oct 27, 1992 | K923339 | TSRH L CONNECTOR -- MODIFICATION Sofamor Danek Mfg., Inc. | KWP |
| Aug 26, 1992 | K912837 | MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS Kirschner Medical Corp. | KWP |
| Jun 19, 1992 | K914306 | TSRH(TM) LATERAL OFFSET PLATE Sofamor Danek Mfg., Inc. | KWP |
| May 12, 1992 | K914966 | TSRH CENTRAL POST HOOKS Sofamor Danek Mfg., Inc. | KWP |
| May 5, 1992 | K920102 | THE SELBY SYSTEM Advanced Spine Fixation Systems, Inc. | KWP |
| Apr 10, 1992 | K920116 | PWB LUMBOSACRAL SPINE SYSTEM Cross Medical Products, Inc. | KWP |
| Mar 23, 1992 | K911663 | CROSSLINK SYSTEM Synthes (Usa) | KWP |
| Jan 22, 1992 | K904243 | TSRH VARIABLE ANGLE SACRAL SCREW Danek Medical, Inc. | KWP |
| Jan 16, 1992 | K913561 | LUQUE SEGMENTAL SPINAL INSTRUMENTATION Zimmer, Inc. | KWP |
| Dec 18, 1991 | K914269 | EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO Scientific Spinal , Ltd. | KWP |
| Oct 25, 1991 | K904520 | RAY SACRAL FIXATION SYSTEM Danek Medical, Inc. | KWP |
| Oct 24, 1991 | K911307 | CROSSLINK PLATE Danek Medical, Inc. | KWP |
| Sep 11, 1991 | K911379 | DANEK SACRAL HOOK, MODIFICATION Danek Medical, Inc. | KWP |
| Sep 6, 1991 | K911319 | TSRH OPEN HEAD BONE SCREW Danek Medical, Inc. | KWP |
| Jun 28, 1991 | K911528 | ISOLA(TM) SPINE SYSTEM - ILIAC SCREW Acromed Corp. | KWP |
| Jun 21, 1991 | K911394 | ISOLA(TM) SPINE SYSTEM--EYE ROD Acromed Corp. | KWP |
| Mar 21, 1991 | K905826 | ISOLA SLOTTED CONNECT/ANGLED SLOTTED CONNECTOR Acromed Corp. | KWP |
| Feb 15, 1991 | K905184 | ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOK Acromed Corp. | KWP |
| Dec 27, 1990 | K903376 | ACROMED SACRAL SCREW Acromed Corp. | KWP |
| Dec 10, 1990 | K902775 | KNIGHT SACRAL SCREW Danek Medical, Inc. | KWP |
| Dec 10, 1990 | K901005 | TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS) Danek Medical, Inc. | KWP |
| Dec 5, 1990 | K903461 | TSRH OFFSET AND SIDE-LOADING HOOKS Danek Medical, Inc. | KWP |
| Nov 5, 1990 | K902397 | MODULOCK POSTERIOR SPINAL FIXATION Zimmer, Inc. | KWP |
| Nov 5, 1990 | K901587 | TSRH SACRAL L-CONNECTOR Danek Medical, Inc. | KWP |
| Aug 21, 1990 | K901590 | DANEK SACRAL HOOK Danek Medical, Inc. | KWP |
| Aug 9, 1990 | K895978 | CHIBA SPINAL SYSTEM Danek Medical, Inc. | KWP |
| Jun 25, 1990 | K896106 | ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS Richards Medical Co., Inc. | KWP |
| Jun 14, 1990 | K896254 | DANEK PRECISION ROD SET Danek Medical, Inc. | KWP |
| Mar 20, 1990 | K895296 | SELBY II INSTRUMENTATION Advanced Spine Fixation | KWP |
| Feb 26, 1990 | K896740 | AXIAL AND OFFSET CROSSLINK PLATES Danek Medical, Inc. | KWP |
| Jan 30, 1990 | K896603 | HSC UNIT ROD Danek Medical, Inc. | KWP |
| Jan 4, 1990 | K890192 | LUQUE III SPINAL SYSTEM AND LUQUE MINI-SET Danek Medical, Inc. | KWP |
| Nov 22, 1989 | K895441 | ACROMED BUTTON SPINAL WIRE Acromed Corp. | KWP |
| Nov 22, 1989 | K895439 | ACROMED BEADED SUBLAMINAR WIRE Acromed Corp. | KWP |
| Nov 22, 1989 | K895413 | ACROMED DOUBLE SUBLAMINAR WIRE Acromed Corp. | KWP |
| Oct 11, 1989 | K894702 | STUART CD UNIVERSAL ROD CONNECTOR CLAMPS Bio-Medical Prosthetics | KWP |
| Oct 10, 1989 | K894472 | CROSS ROUND & SQUARE SPINAL RODS & DIST. SPINAL Buckman Co., Inc. | KWP |
| Jun 22, 1989 | K884998 | SELBY INSTRUMENTATION Advanced Spine Fixation Systems, Inc. | KWP |
| Jun 2, 1989 | K884690 | KIRSCHNER SPINAL FIXATOR KMS-1 Kirschner Medical Corp. | KWP |
| May 3, 1989 | K884161 | ACROMED ILIAC SCREW Buckman Co., Inc. | KWP |
| Apr 26, 1989 | K884163 | ACROMED SPINAL ROD AND SPINAL HOOKS Buckman Co., Inc. | KWP |
| Apr 6, 1989 | K890187 | THE C-S DISTRACTION ROD ASSEMBLY Orthopedic Systems, Inc. | KWP |
| Apr 6, 1989 | K883783 | TSRH SACRAL SPINAL SCREW Warsaw Orthopedic, Inc. | KWP |
| Feb 24, 1989 | K884688 | MODULAR SPINAL FIXATION & LOCKING HOOK SPINAL ROD Synthes (Usa) | KWP |
| Jan 27, 1989 | K884585 | LEA PLAZA SPINAL FRAME SYSTEM Orthomet, Inc. | KWP |
| Dec 29, 1988 | K884263 | ROGOZINSKI SPINAL SYSTEM Richards Medical Co., Inc. | KWP |
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