DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX
FDA 510(k) clearance K040262 · decided 2005-03-17
Clearance details
- K-number
- K040262
- Device name
- DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX
- Applicant
- Musculoskeletal Transplant Foundation
- Decision
- Substantially Equivalent
- Date received
- 2004-02-04
- Decision date
- 2005-03-17
- Days to decision
- 407 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Edison, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created oss recall (Z-0323-2024) | Musculoskeletal Transplant Foundation, Inc. | 2023-11-17 |
| DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler. recall (Z-1455-2015) | Musculoskeletal Transplant Foundation, Inc. | 2015-04-17 |