FDA Product Code
FDA Product Code MQP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3060
510(k) Clearances — 279 records · page 3 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K041407 | TITANIUM MESH IMPLANT | Interpore Cross Intl. | 2004-12-29 | Traditional | PDF ↗ |
| K042713 | FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5 | Spine Next America Corporation | 2004-12-29 | Traditional | PDF ↗ |
| K042930 | SPACEVISION CAGE SYSTEM | Spine Vision, Inc. | 2004-12-28 | Traditional | PDF ↗ |
| K042268 | EBI CAS SPINE SPACER SYSTEM | Ebi, L.P. | 2004-10-27 | Special | PDF ↗ |
| K042201 | NOVEL VBR SPINAL SYSTEM | Alphatec/Nexmed | 2004-10-07 | Traditional | PDF ↗ |
| K041389 | SYNTHES CONTOURED SYNMESH SPACER | Synthes Spine | 2004-10-01 | Special | PDF ↗ |
| K041722 | MODIFICATION TO VBR SPINAL SYSTEM | Depuy Spine, Inc. | 2004-09-23 | Special | PDF ↗ |
| K041617 | STALIF TT | Surgicraft , Ltd. | 2004-09-08 | Traditional | PDF ↗ |
| K040928 | EXPANDABLE PEEK VBR IMPLANT | Interpore Cross Intl. | 2004-08-27 | Traditional | PDF ↗ |
| K041939 | BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS | Blackstone Medical, Inc. | 2004-08-17 | Special | PDF ↗ |
| K041888 | CURVED PEEK TETRIS SPINAL IMPLANT | Signus Medizintechnik GmbH | 2004-08-10 | Special | PDF ↗ |
| K041197 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek | 2004-08-09 | Special | PDF ↗ |
| K040731 | STRYKER SPINE VERTEBRAL SPACER | Stryker Spine | 2004-08-05 | Traditional | PDF ↗ |
| K033926 | HOURGLASS VERTEBRAL BODY SPACER | Medtronic Sofamor Danek | 2004-07-07 | Traditional | PDF ↗ |
| K041556 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek | 2004-07-01 | Special | PDF ↗ |
| K041452 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek | 2004-06-24 | Special | PDF ↗ |
| K033663 | SPINAL CONCEPTS INC. CODA | Spinal Concepts, Inc. | 2004-05-27 | Traditional | PDF ↗ |
| K040536 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek | 2004-05-05 | Special | PDF ↗ |
| K040482 | EBI ESL SPINE SPACER SYSTEM | Ebi, L.P. | 2004-04-16 | Traditional | PDF ↗ |
| K040168 | MODIFICATION TO GEO STRUCTURE | Interpore Cross Intl. | 2004-04-08 | Special | PDF ↗ |
| K033702 | BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM | Blackstone Medical, Inc. | 2004-03-31 | Traditional | PDF ↗ |
| K040284 | SUSTAIN RADIOLUCENT SPACER | Globus Medical, Inc. | 2004-03-23 | Special | PDF ↗ |
| K033109 | ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS | Scient'X | 2004-03-23 | Traditional | PDF ↗ |
| K040422 | MODIFICATION TO VERTE-STACK | Medtronic Sofamor Danek | 2004-03-19 | Special | PDF ↗ |
| K032064 | THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM | Theken Surgical,Llc | 2004-02-20 | Traditional | PDF ↗ |
| K033517 | SPINAL CONCEPTS INC. CADENCE AND TRAXIS | Spinal Concepts, Inc. | 2004-02-18 | Special | PDF ↗ |
| K040167 | VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek | 2004-02-18 | Special | PDF ↗ |
| K032371 | TITANIUM MESH SYSTEM | Encore Medical L.P. | 2004-02-12 | Traditional | PDF ↗ |
| K033837 | STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM | Howmedica Osteonics Corp. | 2004-01-08 | Special | PDF ↗ |
| K032812 | ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT | Orthovita, Inc. | 2003-12-08 | Traditional | PDF ↗ |
| K032476 | NUVASIVE MESH | Nuvasive, Inc. | 2003-11-13 | Special | PDF ↗ |
| K032527 | HEDROCEL VERTEBRAL BODY REPLACEMENT | Implex Corp. | 2003-10-31 | Special | PDF ↗ |
| K032700 | BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS | Blackstone Medical, Inc. | 2003-10-09 | Special | PDF ↗ |
| K031672 | SPINAL CONCEPTS, INC. INFIX SYSTEM | Spinal Concepts, Inc. | 2003-08-07 | Traditional | PDF ↗ |
| K031757 | PEEK TETRIS SPINAL IMPLANT | Signus Medical, LLC | 2003-07-30 | Special | PDF ↗ |
| K031780 | VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek | 2003-07-30 | Special | PDF ↗ |
| K031914 | SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE | Spinal Concepts, Inc. | 2003-07-12 | Traditional | PDF ↗ |
| K031823 | HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 | Implex Corp. | 2003-07-11 | Special | PDF ↗ |
| K030744 | BLACKSTONE SURGICAL TITANIUM MESH | Blackstone Medical, Inc. | 2003-06-27 | Traditional | PDF ↗ |
| K031302 | SUSTAIN SPACER | Globus Medical, Inc. | 2003-06-27 | Traditional | PDF ↗ |
| K031635 | DEPUY ACROMED VBR SYSTEM | Depuyacromed | 2003-06-23 | Special | PDF ↗ |
| K030735 | MODIFIED VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek | 2003-04-18 | Special | PDF ↗ |
| K030833 | DEPUY ACROMED VBR SYSTEM | Depuyacromed | 2003-04-10 | Special | PDF ↗ |
| K022793 | TETRIS SPINAL IMPLANT | Signus Medical, LLC | 2003-04-08 | Traditional | PDF ↗ |
| K030736 | VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES | Medtronic Sofamor Danek | 2003-04-02 | Special | PDF ↗ |
| K030601 | VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek | 2003-03-25 | Special | PDF ↗ |
| K024364 | SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW) | Synthes (Usa) | 2003-03-17 | Traditional | PDF ↗ |
| K023319 | NUVASIVE MASH | Nuvasive, Inc. | 2003-03-04 | Traditional | PDF ↗ |
| K024049 | VERTE-SPAN SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2003-02-26 | Special | PDF ↗ |
| K030249 | SURGICAL TITANIUM MESH SYSTEM | Depuyacromed | 2003-02-14 | Special | PDF ↗ |
| K023835 | DEVEX MESH SYSTEM | Depuyacromed | 2003-01-29 | Special | PDF ↗ |
| K022143 | INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD) | Interpore Cross Intl. | 2003-01-23 | Traditional | PDF ↗ |
| K023570 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek | 2002-11-19 | Special | PDF ↗ |
| K022563 | HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 | Implex Corp. | 2002-08-30 | Special | PDF ↗ |
| K021791 | VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek | 2002-08-26 | Traditional | PDF ↗ |
| K021967 | HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2 | Implex Corp. | 2002-07-17 | Special | PDF ↗ |
| K011037 | VERTEBRAL SPACER | Synthes (Usa) | 2002-07-01 | Traditional | PDF ↗ |
| K021025 | MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ | Implex Corp. | 2002-05-20 | Special | PDF ↗ |
| K020887 | EBI AIS SPINE SYSTEM | Ebi, L.P. | 2002-05-16 | Traditional | PDF ↗ |
| K020152 | SYNTHES VERTEBRAL SPACER TI | Synthes (Usa) | 2002-04-16 | Traditional | PDF ↗ |
| K020522 | MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM | Depuyacromed | 2002-03-21 | Special | PDF ↗ |
| K020204 | TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189 | Interpore Cross Intl. | 2002-02-21 | Special | PDF ↗ |
| K020048 | MODIFICATION TO GEO STRUCTURE | Interpore Cross Intl. | 2002-02-06 | Special | PDF ↗ |
| K010378 | HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ | Implex Corp. | 2002-01-28 | Traditional | PDF ↗ |
| K014145 | MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131 | Interpore Cross Intl. | 2002-01-17 | Special | PDF ↗ |
| K011406 | SPINAL MESH SYSTEM | Medtronic Sofamor Danek, Inc. | 2001-12-27 | Traditional | PDF ↗ |
| K013382 | MODIFICATION TO: STACKABLE CAGE SYSTEM | Depuyacromed | 2001-11-07 | Special | PDF ↗ |
| K010989 | TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 8131 | Interpore Cross Intl. | 2001-11-07 | Traditional | PDF ↗ |
| K010930 | LIFT VB SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2001-10-24 | Traditional | PDF ↗ |
| K012254 | VBR | Osteotech, Inc. | 2001-10-16 | Traditional | PDF ↗ |
| K010530 | GEO STRUCTURE | Interpore Cross Intl. | 2001-08-03 | Traditional | PDF ↗ |
| K003709 | SURGICAL DYNAMICS MESH CAGE SYSTEM | United States Surgical, A Division of Tyco Healthc | 2001-07-18 | Traditional | PDF ↗ |
| K003836 | SYNTHES SYNEX SPACER SYSTEM | Synthes | 2001-05-29 | Traditional | PDF ↗ |
| K003043 | SURGICAL TITANIUM MESH SYSTEM | Depuyacromed | 2001-05-08 | Traditional | PDF ↗ |
| K003275 | SYNTHES SYNMESH SPACER SYSTEM | Synthes (Usa) | 2001-04-23 | Traditional | PDF ↗ |
| K003155 | VERTEBRAL BODY REPLACEMENT | Osteotech, Inc. | 2001-01-04 | Traditional | PDF ↗ |
| K001340 | STACKABLE CAGE SYSTEM | Depuyacromed | 2000-07-26 | Traditional | PDF ↗ |
| K983667 | IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE | Ionics Medical Corp. | 2000-07-05 | Traditional | PDF ↗ |
| K990148 | STACKABLE CAGE SYSTEM | Depuy Motech Acromed | 1999-09-03 | Traditional | PDF ↗ |
Product code MQP · Class II · Orthopedic. Data: openFDA.