ALLEZ SPINE CROSS CONNECTORS
FDA 510(k) clearance K070460 · decided 2007-06-11
Clearance details
- K-number
- K070460
- Device name
- ALLEZ SPINE CROSS CONNECTORS
- Applicant
- Allez Spine, LLC
- Decision
- Substantially Equivalent
- Date received
- 2007-02-16
- Decision date
- 2007-06-11
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- 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 |
|---|---|---|
| Allez Spine Cross Connectors; Catalog Number: LG-CC1001Cross Link, Small 30-37mm; LG-CC100 recall (Z-0155-2009) | Allez Spine, LLC | 2008-10-28 |