INTERGRO DBM
FDA 510(k) clearance K031399 · decided 2005-02-18
Clearance details
- K-number
- K031399
- Device name
- INTERGRO DBM
- Applicant
- Interpore Cross Intl.
- Decision
- Substantially Equivalent
- Date received
- 2003-05-05
- Decision date
- 2005-02-18
- Days to decision
- 655 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| InterGro PLUS; DBM in a Lipid Carrier with Calcium Granules; Model Numbers: DBM002, DBM005 recall (Z-0618-2008) | Interpore Cross International Inc | 2008-02-14 |