Company
Orthovita, Inc., dBA Stryker Orthobiologics.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
17recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2015 | Orthovita, Inc., dBA Stryker Orthobiologics. Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone Terminated |
KIH | None listed |
| Mar 30, 2015 | Orthovita, Inc., dBA Stryker Orthobiologics. Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or imp Terminated |
LMH | None listed |
| Jan 7, 2015 | Orthovita, Inc., dBA Stryker Orthobiologics. Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bullet-tip), 11 gauge x 4 inch
2090-0028 Needle (bullet-tip), 11 gauge x 6 inch
2090-0029 Needle (bullet- Terminated |
KNW | K140414 |
| Jan 7, 2015 | Orthovita, Inc., dBA Stryker Orthobiologics. Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch
2110-0524 Beveled Needle, 11 gauge x 6 inch
2110-0506 Diamond Needle, 11 gau Terminated |
KNW | None listed |
| May 24, 2013 | Orthovita, Inc., dBA Stryker Orthobiologics. Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6", Part Number 2110-0503
Product Usage:
Facilitate placement of bone cement in weakened or diminished bo Terminated |
OAR | None listed |
| May 24, 2013 | Orthovita, Inc., dBA Stryker Orthobiologics. Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6", Part Number 2110-0524
Product Usage:
Facilitate placement of bone cement in weakened or diminis Terminated |
OAR | None listed |
| May 24, 2013 | Orthovita, Inc., dBA Stryker Orthobiologics. Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8", Part Number 2110-0502
Product Usage:
Facilitate placement of bone cement in weakened or diminished bo Terminated |
OAR | None listed |
| May 24, 2013 | Orthovita, Inc., dBA Stryker Orthobiologics. Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504
Product Usage:
Facilitate placement of bone cement in weakened or diminished bone Terminated |
OAR | None listed |
| May 24, 2013 | Orthovita, Inc., dBA Stryker Orthobiologics. Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525
Product Usage:
Facilitate placement of bone cement in weakened or diminished bone Terminated |
OAR | None listed |
| May 24, 2013 | Orthovita, Inc., dBA Stryker Orthobiologics. Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4", Part Number 2110-0506
Product Usage:
Facilitate placement of bone cement in weakened or diminis Terminated |
OAR | None listed |
| May 24, 2013 | Orthovita, Inc., dBA Stryker Orthobiologics. Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6", Part Number 2110-0501
Product Usage:
Facilitate placement of bone cement in weakened or diminished bon Terminated |
OAR | None listed |
| May 24, 2013 | Orthovita, Inc., dBA Stryker Orthobiologics. Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526
Product Usage:
Facilitate placement of bone cement in weakened or diminished bo Terminated |
OAR | None listed |
| May 24, 2013 | Orthovita, Inc., dBA Stryker Orthobiologics. Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505
Product Usage:
Facilitate placement of bone cement in weakened or dimin Terminated |
OAR | None listed |
| May 24, 2013 | Orthovita, Inc., dBA Stryker Orthobiologics. Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504
Product Usage:
Facilitate placement of bone cement in weakened o Terminated |
OAR | None listed |
| May 24, 2013 | Orthovita, Inc., dBA Stryker Orthobiologics. Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0501
Product Usage:
Facilitate placement of bone cement in weakened o Terminated |
OAR | None listed |
| May 24, 2013 | Orthovita, Inc., dBA Stryker Orthobiologics. Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 6", Part Number 2090-0505
Product Usage:
Facilitate placement of bone cement in weakened o Terminated |
OAR | None listed |
| May 24, 2013 | Orthovita, Inc., dBA Stryker Orthobiologics. Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0502
Product Usage:
Facilitate placement of bone cement in weakened Terminated |
OAR | None listed |