Panels › Orthopedic › Product code KWQ · Class 2
Appliance, Fixation, Spinal Intervertebral Body
Regulation 888.3060
11510(k)s in 12 months (668 all time)
1recalls in 12 months (214 all time)
165recalls that name a 510(k)
Top companies in KWQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Spine | 6 | 38 |
| Alphatec Spine, Inc. | 9 | 32 |
| RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | 0 | 41 |
| Zimmer, Inc. | 1 | 37 |
| Medtronic Sofamor Danek | 29 | 8 |
| Nuvasive, Inc. | 21 | 0 |
| K2m | 20 | 0 |
| Depuy Spine, Inc. | 10 | 8 |
| Blackstone Medical, Inc. | 13 | 3 |
| Globus Medical, Inc. | 15 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 16, 1998 | K973854 | ORION ANTERIOR CERVICAL PLATE SYSTEM Sofamor Danek USA,Inc. | KWQ |
| Mar 13, 1998 | K974706 | AESCULAP ABC CERVICAL PLATING SYSTEM Aesculap, Inc. | KWQ |
| Mar 5, 1998 | K974757 | KANEDA ANTERIOR SCOLIOSIS SYSTEM KASS Acromed Corp. | KWQ |
| Mar 2, 1998 | K974525 | SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM Synthes Spine | KWQ |
| Feb 19, 1998 | K974435 | MICHELSON ANTERIOR CERVICAL PLATE SYSTEM Wrightmedicaltechnologyinc | KWQ |
| Jan 13, 1998 | K973923 | EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM Ebi Electro Biology | KWQ |
| Nov 3, 1997 | K973060 | DEPUY MOTECH PROFILE ANTERIOR THORACOLUMBAR PLATE SYSTEM Depuy, Inc. | KWQ |
| Nov 3, 1997 | K971730 | DEPUY MOTECH PEAK POLYAXIAL ANTERIOR CERVICAL PLATE SYSTEM Depuy, Inc. | KWQ |
| Oct 16, 1997 | K971883 | SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM Synthes (Usa) | KWQ |
| Oct 1, 1997 | K972718 | M-2 ANTERIOR PLATE SYSTEM Acromed Corp. | KWQ |
| Aug 14, 1997 | K970635 | TITANIUM SPINAL ROD SYSTEM Smith & Nephew, Inc., Orthopaedic Div. | KWQ |
| Aug 1, 1997 | K970048 | SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS) Synthes (Usa) | KWQ |
| Jul 30, 1997 | K963780 | DUAL ROD ANTERIOR FIXATOR SYSTEM Sofamor Danek USA,Inc. | KWQ |
| Jun 11, 1997 | K971248 | KANEDA SR ANTERIOR SPINAL SYSTEM Acromed Corp. | KWQ |
| Jun 11, 1997 | K970955 | ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM Acromed Corp. | KWQ |
| May 2, 1997 | K970806 | ACPII ANTERIOR CERVICAL PLATE SYSTEM Sofamor Danek USA,Inc. | KWQ |
| May 2, 1997 | K964797 | EBI SPINELINK SYSTEM Electro-Biology, Inc. | KWQ |
| Apr 3, 1997 | K970462 | ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM Acromed Corp. | KWQ |
| Mar 17, 1997 | K965193 | LIBERTY ANTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. | KWQ |
| Mar 17, 1997 | K964416 | SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM Synthes (Usa) | KWQ |
| Feb 19, 1997 | K953978 | ANTERIOR DYNAMIZED SYSTEM Acromed Corp. | KWQ |
| Feb 6, 1997 | K964623 | TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. | KWQ |
| Dec 27, 1996 | K962486 | DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM Depuy, Inc. | KWQ |
| Nov 27, 1996 | K963655 | CD HORIZON ANTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. | KWQ |
| Mar 13, 1996 | K955730 | EBI ANTERIOR CERVICAL SPINE SYSTEM Electro-Biology, Inc. | KWQ |
| Jan 30, 1996 | K940744 | SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION Sofamor Co., FR | KWQ |
| Nov 9, 1995 | K953730 | CODMAN ANTERIOR CERVICAL PLATE SYSTEM Johnson & Johnson Professionals, Inc. | KWQ |
| Nov 6, 1995 | K950011 | COHORT(TM) ANTERIOR PLATE SYSTEM (APS) Cohort Medical Products Group, Inc. | KWQ |
| Nov 2, 1995 | K953720 | AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION Aesculap, Inc. | KWQ |
| Oct 25, 1995 | K950709 | SYNERGY TI ANTERIOR SPINAL SYSTEM Cross Medical Products, Inc. | KWQ |
| Oct 11, 1995 | K950209 | J.B.S. ANTERIOR SPINE SYSTEM(R) J.B.S. (Usa), Inc. | KWQ |
| Aug 25, 1995 | K943725 | UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM Synthes Spine | KWQ |
| Jul 20, 1995 | K945700 | SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM Synthes (Usa) | KWQ |
| Feb 9, 1995 | K943819 | ISOLA ANTERIOR SYSTEM Acromed Corp. | KWQ |
| Feb 8, 1995 | K943694 | EBI ANTERIOR CERVICAL SPINE SYSTEM Electro-Biology, Inc. | KWQ |
| Dec 19, 1994 | K943523 | ANTERIOR CERVIAL PLATING SYSTEM Smith & Nephew Richards, Inc. | KWQ |
| Dec 5, 1994 | K941367 | WEBB-MORLEY SPINE SYSTEM Electro-Biology, Inc. | KWQ |
| Nov 8, 1994 | K934756 | CODMAN ANTERIOR CERVICAL SPINE PLATE SYSTEM Codman & Shurtleff, Inc. | KWQ |
| Oct 20, 1994 | K934429 | ANTERIOR SPINE SYSTEM Buckman Co., Inc. | KWQ |
| Aug 15, 1994 | K936269 | CASPAR TITANIUM ALLOY BONE SCREWS Aesculap, Inc. | KWQ |
| Aug 4, 1994 | K931653 | SPINE-TECH CERVICAL FIXATION SYSTEM Spinal Technologies | KWQ |
| Nov 5, 1993 | K925351 | SYNTHES(U.S.A.) ANTERIOR SPINAL PLATE Synthes (Usa) | KWQ |
| Oct 12, 1993 | K926453 | SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE Synthes (Usa) | KWQ |
| Oct 1, 1993 | K930807 | SENTRY ANTERIOR SPINAL SYSTEM Sofamor Danek Mfg., Inc. | KWQ |
| Jun 24, 1993 | K922855 | SYNTHES UNIVERSAL SPINE ROD AND SCREW FIXATION SYS Synthes (Usa) | KWQ |
| May 20, 1993 | K923703 | KANEDA ANTERIOR SPINAL MULTISEGMENTAL FIXATION DEV Acromed Corp. | KWQ |
| May 19, 1993 | K923242 | CROSSLINK AXIAL AND OFFSET PLATES Sofamor Danek Mfg., Inc. | KWQ |
| May 19, 1993 | K922543 | Z-PLATE ANTERIOR FIXATION SYSTEM Sofamor Danek Mfg., Inc. | KWQ |
| Dec 17, 1992 | K923446 | STERILE DYNA LOK ANTERIOR PLATING SYSTEM Sofamor Danek Mfg., Inc. | KWQ |
| Nov 6, 1992 | K922087 | ANTERIOR CERVICAL PLATE SYSTEM Sofamor Danek Mfg., Inc. | KWQ |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.