OSSEOTITE II MODEL XIFOSSXXX
FDA 510(k) clearance K100724 · decided 2011-04-01
Clearance details
- K-number
- K100724
- Device name
- OSSEOTITE II MODEL XIFOSSXXX
- Applicant
- Biomet 3i, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-03-15
- Decision date
- 2011-04-01
- Days to decision
- 382 days
- Clearance type
- Traditional
- Product code
- DZE
- Device class
- 2
- Regulation number
- 872.3640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Palm Beach Gardens, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants. recall (Z-1410-2015) | Biomet 3i, LLC | 2015-04-10 |
| Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: recall (Z-2207-2013) | Biomet 3i, LLC | 2013-09-16 |
| Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 1 recall (Z-0297-2013) | Biomet 3i, LLC | 2012-11-16 |
| Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The produ recall (Z-0298-2013) | Biomet 3i, LLC | 2012-11-16 |
| ***REF IOSS511***OSSEOTITE Certain Implant 5 x 11.5mm***LOT 910695***Sterile using Radiati recall (Z-0171-2012) | Biomet 3i, LLC | 2011-11-08 |