FDA Product Code
FDA Product Code KWP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3050
510(k) Clearances — 430 records · page 4 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K964275 | ALPHA POSTERIOR SPINAL SYSTEM | Sofamor Danek USA,Inc. | 1997-01-14 | Traditional | PDF ↗ |
| K962314 | HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM | Osteonics Corp. | 1996-12-09 | Traditional | PDF ↗ |
| K961633 | CD HORIZON SPINAL SYSTEM | Sofamor Danek USA,Inc. | 1996-12-05 | Traditional | PDF ↗ |
| K962984 | ISOLA PEDIATRIC COMPONENTS | Acromed Corp. | 1996-11-27 | Traditional | PDF ↗ |
| K963639 | ACROMED PEDICLE SCREW | Acromed Corp. | 1996-11-14 | Traditional | PDF ↗ |
| K955807 | COTREL-DUBOUSSET (CD) SPINAL | Sofamor Danek USA,Inc. | 1996-10-01 | Traditional | PDF ↗ |
| K955365 | COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM | Sofamor Danek USA,Inc. | 1996-03-27 | Traditional | PDF ↗ |
| K955864 | J.B. S. C1-C2 CLAMP | J.B.S., S.A. | 1996-03-15 | Traditional | PDF ↗ |
| K955927 | BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION) | Arcan Orthopaedic Corp. | 1996-03-13 | Traditional | PDF ↗ |
| K954696 | ROGOZINSKI THORACOLUMBAR SPINAL ROD | Smith & Nephew Richards, Inc. | 1996-03-11 | Traditional | PDF ↗ |
| K955348 | TITANIUM MOSS MIAMI SPINAL SYSTEM | Depuy, Inc. | 1996-02-16 | Traditional | PDF ↗ |
| K951846 | MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS | Alphatec Mfg., Inc. | 1996-02-14 | Traditional | PDF ↗ |
| K951164 | CD LIBERTY POSTERIOR SPINCAL SYSTEM | Sofamor Danek USA,Inc. | 1996-02-09 | Traditional | PDF ↗ |
| K955173 | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) | Osteotech, Inc. | 1996-02-09 | Traditional | PDF ↗ |
| K954770 | CENTRA-LINE GRAPPLE, VARIFIX SYSTEM | Advanced Spine Fixation Systems, Inc. | 1996-01-25 | Traditional | PDF ↗ |
| K954645 | TITANIUM GDLH POSTERIOR SPINAL SYSTEM | Sofamor Danek USA,Inc. | 1996-01-16 | Traditional | PDF ↗ |
| K953599 | CLAMP ASSEMBLY | J.B.S., S.A. | 1995-12-19 | Traditional | PDF ↗ |
| K936294 | SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS | Sofamor Danek Mfg., Inc. | 1995-12-19 | Traditional | PDF ↗ |
| K942432 | J.B.S. CERVICAL SPINE SYSTEM | J.B.S., S.A. | 1995-07-11 | Traditional | PDF ↗ |
| K945781 | WEBB-MORLEY SPINE SYSTEM | Electro-Biology, Inc. | 1995-06-22 | Traditional | PDF ↗ |
| K945435 | BRYAN POSTERIOR SPINAL FIXATOR (BPSF) | Arcan Orthopaedic Corp. | 1995-05-31 | Traditional | PDF ↗ |
| K945022 | APOFIX CERVICAL SPINE FIXATION | Sofamor Co. | 1995-05-15 | Traditional | PDF ↗ |
| K931381 | AME UNIVERSAL FIXATION SYSTEM | American Medical Electronics, Inc. | 1995-02-01 | Traditional | PDF ↗ |
| K935113 | J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE | J.B.S., S.A. | 1994-10-19 | Traditional | PDF ↗ |
| K930009 | STRYKER 2S SPINAL SYSTEM | Stryker Corp. | 1994-09-01 | Traditional | PDF ↗ |
| K933881 | DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM | Depuy, Inc. | 1994-07-12 | Traditional | PDF ↗ |
| K930515 | ALPHA SPINAL SYSTEM | Alphatec Mfg., Inc. | 1994-06-29 | Traditional | PDF ↗ |
| K930657 | D-C-S SYSTEM | Pina-Vertriebs | 1994-06-29 | Traditional | PDF ↗ |
| K934582 | GDLH VARIABLE ANGLE CONNECTOR | Danek Group, Inc. | 1994-06-21 | Traditional | PDF ↗ |
| K934860 | TI-FRAME | Johnson & Johnson Professionals, Inc. | 1994-06-03 | Traditional | PDF ↗ |
| K934007 | SOFAMOR ORFIL SPINE FIXATION SYSTEM | Sofamor Co. | 1994-06-02 | Traditional | PDF ↗ |
| K933205 | TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON | Danek Medical, Inc. | 1994-05-04 | Traditional | PDF ↗ |
| K931225 | LOW PROFILE MID CROSS BRACING | Advanced Spine Fixation Systems, Inc. | 1994-05-02 | Traditional | PDF ↗ |
| K930891 | SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST | Synthes (Usa) | 1994-04-29 | Traditional | PDF ↗ |
| K931208 | LOW PROFILE SLEAVE NUT ASSEMBLY | Advanced Spine Fixation Systems, Inc. | 1994-03-28 | Traditional | PDF ↗ |
| K914548 | BRYAN SPINAL FIXATER (BSF) | Arcan Orthopaedic Corp. | 1994-03-28 | Traditional | PDF ↗ |
| K930531 | AME(R) RIGID FIXATION SYSTEM | American Medical Electronics, Inc. | 1994-02-01 | Traditional | PDF ↗ |
| K930710 | SENTRY POSTERIOR SPINAL SYSTEM | Sofamor Danek Mfg., Inc. | 1993-10-01 | Traditional | PDF ↗ |
| K924474 | SELBY INSTRUMENTATION | Advanced Spine Fixation Systems, Inc. | 1993-09-21 | Traditional | PDF ↗ |
| K921056 | COTREL - DUBOUSSET SPINE IMPLANTS | Buckman Co., Inc. | 1993-06-24 | Traditional | PDF ↗ |
| K921948 | SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST | Synthes (Usa) | 1993-06-22 | Traditional | PDF ↗ |
| K921767 | COMPACT COTREL -- DUBOUSSET SPINE SYSTEM | Buckman Co., Inc. | 1993-06-22 | Traditional | PDF ↗ |
| K924142 | CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT | Codman & Shurtleff, Inc. | 1993-06-15 | Traditional | PDF ↗ |
| K915672 | EDWARDS ADJUSTABLE CONNECTORS | Scientific Spinal , Ltd. | 1993-05-26 | Traditional | PDF ↗ |
| K922672 | AUGMENT POSTERIOR SPINAL FIXATION SYSTEM | Sofamor Danek Mfg., Inc. | 1993-05-18 | Traditional | PDF ↗ |
| K921256 | LUQUE V SPINAL SYSTEM | Sofamor Danek Mfg., Inc. | 1993-05-18 | Traditional | PDF ↗ |
| K922504 | ISOLA(R) TANDEM CONNECTOR | Acromed Corp. | 1993-05-18 | Traditional | PDF ↗ |
| K924381 | PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS | Cross Medical Products, Inc. | 1993-05-18 | Traditional | PDF ↗ |
| K925811 | TSRH CENTRAL POST HOOKS | Sofamor Danek Mfg., Inc. | 1993-05-18 | Traditional | PDF ↗ |
| K920546 | PARAGON POSTERIOR SPINAL SYSTEM | Sofamor Danek Mfg., Inc. | 1993-01-21 | Traditional | PDF ↗ |
| K920392 | ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION | Acromed Corp. | 1992-12-31 | Traditional | PDF ↗ |
| K921090 | ISOLA(R) TRANSVERSE ROD DUAL CONNECTOR | Acromed Corp. | 1992-12-31 | Traditional | PDF ↗ |
| K922238 | LEAPLAZA FRAME | Spintech, Inc. | 1992-12-23 | Traditional | PDF ↗ |
| K922520 | MODIFIED TSRH CENTRAL POST HOOKS | Sofamor Danek Mfg., Inc. | 1992-11-16 | Traditional | PDF ↗ |
| K923339 | TSRH L CONNECTOR -- MODIFICATION | Sofamor Danek Mfg., Inc. | 1992-10-27 | Traditional | PDF ↗ |
| K912837 | MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS | Kirschner Medical Corp. | 1992-08-26 | Traditional | PDF ↗ |
| K914306 | TSRH(TM) LATERAL OFFSET PLATE | Sofamor Danek Mfg., Inc. | 1992-06-19 | Traditional | PDF ↗ |
| K914966 | TSRH CENTRAL POST HOOKS | Sofamor Danek Mfg., Inc. | 1992-05-12 | Traditional | PDF ↗ |
| K920102 | THE SELBY SYSTEM | Advanced Spine Fixation Systems, Inc. | 1992-05-05 | Traditional | PDF ↗ |
| K920116 | PWB LUMBOSACRAL SPINE SYSTEM | Cross Medical Products, Inc. | 1992-04-10 | Traditional | PDF ↗ |
| K911663 | CROSSLINK SYSTEM | Synthes (Usa) | 1992-03-23 | Traditional | PDF ↗ |
| K904243 | TSRH VARIABLE ANGLE SACRAL SCREW | Danek Medical, Inc. | 1992-01-22 | Traditional | PDF ↗ |
| K913561 | LUQUE SEGMENTAL SPINAL INSTRUMENTATION | Zimmer, Inc. | 1992-01-16 | Traditional | PDF ↗ |
| K914269 | EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO | Scientific Spinal , Ltd. | 1991-12-18 | Traditional | PDF ↗ |
| K904520 | RAY SACRAL FIXATION SYSTEM | Danek Medical, Inc. | 1991-10-25 | Traditional | PDF ↗ |
| K911307 | CROSSLINK PLATE | Danek Medical, Inc. | 1991-10-24 | Traditional | PDF ↗ |
| K911379 | DANEK SACRAL HOOK, MODIFICATION | Danek Medical, Inc. | 1991-09-11 | Traditional | PDF ↗ |
| K911319 | TSRH OPEN HEAD BONE SCREW | Danek Medical, Inc. | 1991-09-06 | Traditional | PDF ↗ |
| K911528 | ISOLA(TM) SPINE SYSTEM - ILIAC SCREW | Acromed Corp. | 1991-06-28 | Traditional | PDF ↗ |
| K911394 | ISOLA(TM) SPINE SYSTEM--EYE ROD | Acromed Corp. | 1991-06-21 | Traditional | PDF ↗ |
| K905826 | ISOLA SLOTTED CONNECT/ANGLED SLOTTED CONNECTOR | Acromed Corp. | 1991-03-21 | Traditional | PDF ↗ |
| K905184 | ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOK | Acromed Corp. | 1991-02-15 | Traditional | PDF ↗ |
| K903376 | ACROMED SACRAL SCREW | Acromed Corp. | 1990-12-27 | Traditional | PDF ↗ |
| K901005 | TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS) | Danek Medical, Inc. | 1990-12-10 | Traditional | PDF ↗ |
| K902775 | KNIGHT SACRAL SCREW | Danek Medical, Inc. | 1990-12-10 | Traditional | PDF ↗ |
| K903461 | TSRH OFFSET AND SIDE-LOADING HOOKS | Danek Medical, Inc. | 1990-12-05 | Traditional | PDF ↗ |
| K902397 | MODULOCK POSTERIOR SPINAL FIXATION | Zimmer, Inc. | 1990-11-05 | Traditional | PDF ↗ |
| K901587 | TSRH SACRAL L-CONNECTOR | Danek Medical, Inc. | 1990-11-05 | Traditional | PDF ↗ |
| K901590 | DANEK SACRAL HOOK | Danek Medical, Inc. | 1990-08-21 | Traditional | PDF ↗ |
| K895978 | CHIBA SPINAL SYSTEM | Danek Medical, Inc. | 1990-08-09 | Traditional | PDF ↗ |
| K896106 | ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS | Richards Medical Co., Inc. | 1990-06-25 | Traditional | PDF ↗ |
| K896254 | DANEK PRECISION ROD SET | Danek Medical, Inc. | 1990-06-14 | Traditional | PDF ↗ |
| K895296 | SELBY II INSTRUMENTATION | Advanced Spine Fixation | 1990-03-20 | Traditional | PDF ↗ |
| K896740 | AXIAL AND OFFSET CROSSLINK PLATES | Danek Medical, Inc. | 1990-02-26 | Traditional | PDF ↗ |
| K896603 | HSC UNIT ROD | Danek Medical, Inc. | 1990-01-30 | Traditional | PDF ↗ |
| K890192 | LUQUE III SPINAL SYSTEM AND LUQUE MINI-SET | Danek Medical, Inc. | 1990-01-04 | Traditional | PDF ↗ |
| K895441 | ACROMED BUTTON SPINAL WIRE | Acromed Corp. | 1989-11-22 | Traditional | PDF ↗ |
| K895413 | ACROMED DOUBLE SUBLAMINAR WIRE | Acromed Corp. | 1989-11-22 | Traditional | PDF ↗ |
| K895439 | ACROMED BEADED SUBLAMINAR WIRE | Acromed Corp. | 1989-11-22 | Traditional | PDF ↗ |
| K894702 | STUART CD UNIVERSAL ROD CONNECTOR CLAMPS | Bio-Medical Prosthetics | 1989-10-11 | Traditional | PDF ↗ |
| K894472 | CROSS ROUND & SQUARE SPINAL RODS & DIST. SPINAL | Buckman Co., Inc. | 1989-10-10 | Traditional | PDF ↗ |
| K884998 | SELBY INSTRUMENTATION | Advanced Spine Fixation Systems, Inc. | 1989-06-22 | Traditional | PDF ↗ |
| K884690 | KIRSCHNER SPINAL FIXATOR KMS-1 | Kirschner Medical Corp. | 1989-06-02 | Traditional | PDF ↗ |
| K884161 | ACROMED ILIAC SCREW | Buckman Co., Inc. | 1989-05-03 | Traditional | PDF ↗ |
| K884163 | ACROMED SPINAL ROD AND SPINAL HOOKS | Buckman Co., Inc. | 1989-04-26 | Traditional | PDF ↗ |
| K890187 | THE C-S DISTRACTION ROD ASSEMBLY | Orthopedic Systems, Inc. | 1989-04-06 | Traditional | PDF ↗ |
| K883783 | TSRH SACRAL SPINAL SCREW | Warsaw Orthopedic, Inc. | 1989-04-06 | Traditional | PDF ↗ |
| K884688 | MODULAR SPINAL FIXATION & LOCKING HOOK SPINAL ROD | Synthes (Usa) | 1989-02-24 | Traditional | PDF ↗ |
| K884585 | LEA PLAZA SPINAL FRAME SYSTEM | Orthomet, Inc. | 1989-01-27 | Traditional | PDF ↗ |
| K884263 | ROGOZINSKI SPINAL SYSTEM | Richards Medical Co., Inc. | 1988-12-29 | Traditional | PDF ↗ |
Product code KWP · Class II · Orthopedic. Data: openFDA.