Biocomposites, Ltd.
Medical device manufacturer in Keele, GB.
27510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K251680 | Biosteon® ScrewMAI · Traditional | 02/17/2026SE |
| K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerKWL · Traditional | 06/12/2025SE |
| K250521 | NanoBone® SBX Putty ; NanoBone® QDMQV · Traditional | 04/07/2025SE |
| K212721 | Genex Bone Graft SubstituteMQV · Traditional | 02/04/2022SE |
| K141830 | Stimulan Kit, Stimulan Rapid CureMQV · Traditional | 01/23/2015SE |
| K082381 | GenexMQV · Traditional | 11/14/2008SE |
| K082383 | Fortoss VitalLYC · Special | 09/05/2008SE |
| K073341 | Genex PuttyMQV · Traditional | 07/09/2008SE |
| K081428 | Modification to Doubleplay Suture AnchorHWC · Special | 06/20/2008SE |
| K072127 | DominatorHWC · Special | 08/31/2007SE |
| K071952 | Graftlock Screw, ST ScrewHWC · Special | 08/14/2007SE |
| K071115 | Modification to Bilok ST ScrewHWC · Special | 05/17/2007SE |
| K071091 | Modification to Bilok ScrewHWC · Special | 05/17/2007SE |
| K061949 | Doubleplay Suture AnchorHWC · Traditional | 09/25/2006SE |
| K061311 | Allogran-RMQV · Traditional | 09/22/2006SE |
| K050170 | Fortoss Vital Bone Graft SubstituteLYC · Traditional | 08/26/2005SE |
| K043514 | Allogran-N-Bone Void FillerMQV · Traditional | 01/21/2005SE |
| K040265 | Little Grafter ScrewHWC · Traditional | 05/28/2004SE |
| K040600 | Genex Bone Graft SubstituteMQV · Traditional | 05/07/2004SE |
| K033792 | Bilok ST ScrewHWC · Traditional | 03/01/2004SE |
| K021551 | Stimulan - Calcium Sulfate Bone Void Filler KitMQV · Traditional | 11/01/2002SE |
| K021351 | Biosteon Cross PinHWC · Traditional | 10/17/2002SE |
| K003954 | Stimulan - Calcium Sulfate Bone Void Filler KitMQV · Traditional | 07/12/2001SE |
| K003641 | Biolok Screw, Biosteon ScrewHWC · Traditional | 02/08/2001SE |
| K002070 | Biolok ScrewHWC · Traditional | 08/25/2000SE |
| K001724 | Stimulan -Calcium Sulfate Bone Void FilterMQV · Traditional | 08/04/2000SE |
| K993238 | Fortoss-CemaLYC · Traditional | 01/14/2000SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0638-2021 Class II | Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler…The product is mislabeled. | 11/12/2020Terminated |