MODIFICATION TO GEO STRUCTURE
FDA 510(k) clearance K040168 · decided 2004-04-08
Clearance details
- K-number
- K040168
- Device name
- MODIFICATION TO GEO STRUCTURE
- Applicant
- Interpore Cross Intl.
- Decision
- Substantially Equivalent
- Date received
- 2004-01-26
- Decision date
- 2004-04-08
- Days to decision
- 73 days
- Clearance type
- Special
- Product code
- MQP
- Device class
- 2
- Regulation number
- 888.3060
- 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 |
|---|---|---|
| Spinal Implant, Catalog number: 1000-3000 through 1000-3015 (9 catalog numbers) recall (Z-0530-05) | Interpore Cross International Inc | 2005-02-04 |