Company ยท US
Orthovita, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2017. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 12 |
| FMF | Syringe, Piston | 4 |
| LYC | Bone Grafting Material, Synthetic | 3 |
| KNW | Instrument, Biopsy | 2 |
| HAW | Neurological Stereotaxic Instrument | 1 |
| KIH | Dispenser, Cement | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 1 |
| NDN | Cement, Bone, Vertebroplasty | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 2, 2017 | K163621 | Vitoss Bioactive (BA) Injectable Orthovita, Inc. | MQV |
| Oct 6, 2016 | K161447 | HydroSet XT Orthovita, Inc. | MQV |
| Feb 12, 2016 | K153608 | Vitoss BiModal Bone Graft Substitute Foam Strip Orthovita, Inc. | MQV |
| Dec 18, 2015 | K153306 | Imbibe Needle Orthovita, Inc. | KNW |
| Jun 5, 2014 | K140868 | STRYKER KWIC NEEDLE Orthovita, Inc. | HAW |
| Apr 1, 2014 | K140414 | IMBIBE NEEDLE Orthovita, Inc. | LXH |
| Feb 7, 2011 | K103173 | VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE Orthovita, Inc. | MQV |
| Jan 25, 2011 | K101171 | ORTHOVITA PEEK SPACER Orthovita, Inc. | ODP |
| Oct 27, 2010 | K102545 | FM-02 BONE GRAFT SUBSTITUTE Orthovita, Inc. | MQV |
| Sep 27, 2010 | K091618 | VITOMATRIX Orthovita, Inc. | LYC |
| Jun 5, 2009 | K080108 | CORTOSS BONE AUGMENTATION MATERIAL Orthovita, Inc. | NDN |
| Nov 6, 2008 | K083033 | VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE Orthovita, Inc. | MQV |
| Jun 17, 2008 | K081439 | VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE Orthovita, Inc. | MQV |
| Sep 18, 2007 | K072184 | VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE Orthovita, Inc. | MQV |
| Oct 19, 2005 | K052173 | VITAGEL SURGICAL HEMOSTAT SPRAY SET Orthovita, Inc. | FMF |
| Jun 3, 2005 | K050795 | IMBIBE BONE MARROW ASPIRATION NEEDLE Orthovita, Inc. | KNW |
| Dec 19, 2003 | K032288 | VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL Orthovita, Inc. | MQV |
| Dec 8, 2003 | K032812 | ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT Orthovita, Inc. | MQP |
| Nov 5, 2003 | K032130 | VITOSS-FILLED CARTRIDGE Orthovita, Inc. | MQV |
| Aug 29, 2003 | K032409 | VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER Orthovita, Inc. | MQV |
| Apr 16, 2003 | K030208 | IMBIBE II SYRINGE Orthovita, Inc. | FMF |
| Mar 11, 2003 | K023074 | IMBIBE BONE MARROW ASPIRATION SYRINGE Orthovita, Inc. | FMF |
| Sep 19, 2001 | K011087 | ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE Orthovita, Inc. | FMF |
| Dec 14, 2000 | K994337 | VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER Orthovita Co. | MQV |
| Dec 19, 1995 | K952922 | BIOGRAN BIOACTIVE GLASS SYNTHETIC BONE GRAFT MATERIAL Orthovita Co. | LYC |
| Feb 10, 1995 | K941780 | ORTHOVITA BIOGRAN Orthovita Co. | LYC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2011 | Orthovita, Inc. Orthovita(R) Cortoss(TM) Delivery Gun
Product Usage: Used for the application of Cortoss(TM) Bone Augmentation Material Terminated |
KIH | K080108 |