THERILINK BONE VOID FILLER
FDA 510(k) clearance K040134 · decided 2004-03-09
Clearance details
- K-number
- K040134
- Device name
- THERILINK BONE VOID FILLER
- Applicant
- Therics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-01-21
- Decision date
- 2004-03-09
- Days to decision
- 48 days
- Clearance type
- Special
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Numb recall (Z-1965-2009) | Theken Spine LLC | 2009-09-03 |