Biocomposites, Ltd.
FDA 510(k) & PMA Approved Devices — 26 products
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Total Devices26
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K251680 | Biosteon® Screw | MAI | 2026-02-17 | View |
| 510(k) | K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer | KWL | 2025-06-12 | View |
| 510(k) | K250521 | NanoBone® SBX Putty ; NanoBone® QD | MQV | 2025-04-07 | View |
| 510(k) | K212721 | Genex Bone Graft Substitute | MQV | 2022-02-04 | View |
| 510(k) | K082381 | GENEX | MQV | 2008-11-14 | View |
| 510(k) | K082383 | FORTOSS VITAL | LYC | 2008-09-05 | View |
| 510(k) | K073341 | GENEX PUTTY | MQV | 2008-07-09 | View |
| 510(k) | K081428 | MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR | HWC | 2008-06-20 | View |
| 510(k) | K072127 | DOMINATOR | HWC | 2007-08-31 | View |
| 510(k) | K071952 | GRAFTLOCK SCREW, ST SCREW | HWC | 2007-08-14 | View |
| 510(k) | K071091 | MODIFICATION TO BILOK SCREW | HWC | 2007-05-17 | View |
| 510(k) | K071115 | MODIFICATION TO BILOK ST SCREW | HWC | 2007-05-17 | View |
| 510(k) | K061949 | DOUBLEPLAY SUTURE ANCHOR | HWC | 2006-09-25 | View |
| 510(k) | K061311 | ALLOGRAN-R | MQV | 2006-09-22 | View |
| 510(k) | K050170 | FORTOSS VITAL BONE GRAFT SUBSTITUTE | LYC | 2005-08-26 | View |
| 510(k) | K043514 | ALLOGRAN-N-BONE VOID FILLER | MQV | 2005-01-21 | View |
| 510(k) | K040265 | LITTLE GRAFTER SCREW | HWC | 2004-05-28 | View |
| 510(k) | K040600 | GENEX BONE GRAFT SUBSTITUTE | MQV | 2004-05-07 | View |
| 510(k) | K033792 | BILOK ST SCREW | HWC | 2004-03-01 | View |
| 510(k) | K021551 | STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT | MQV | 2002-11-01 | View |
No matching devices.
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