THERIGRAFT TCP PUTTY BONE VOID FILLER
FDA 510(k) clearance K053228 · decided 2006-01-31
Clearance details
- K-number
- K053228
- Device name
- THERIGRAFT TCP PUTTY BONE VOID FILLER
- Applicant
- Therics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2005-11-18
- Decision date
- 2006-01-31
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Princeton, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is delivered i recall (Z-0169-2011) | Theken Spine Llc | 2010-11-01 |
| FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in a recall (Z-2375-2008) | Theken Spine LLC | 2008-09-18 |