MASTERGRAFT Contain
by Medtronic Sofamor Danek USA, Inc.
510(k) K151172
MASTERGRAFT Contain is a Class II device made by Medtronic Sofamor Danek USA, Inc., cleared under FDA 510(k) K151172 on 14 Aug 2015, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK151172 | Date14 Aug 2015 | StatusActive |
Official records
- FDA 510(k) database K151172
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQV
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3045
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K151172
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| MASTERGRAFT® Contain 7800505 | 7800505 | 00643169585447 | Height 2.0 cm; Length 5.0 cm; Depth 1.2 cm | No longer on the market |
| MASTERGRAFT® Contain 7800510 | 7800510 | 00643169585461 | Height 2.0 cm; Depth 1.2 cm; Length 10.0 cm | On the market |
| MASTERGRAFT® Contain 7800520 | 7800520 | 00643169585478 | Length 10.0 cm; Depth 1.2 cm; Height 2.0 cm | On the market |
| MASTERGRAFT® Contain 7800555 | 7800555 | 00643169585454 | Depth 1.2 cm; Length 5.0 cm; Height 2.0 cm | No longer on the market |
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Other devices filed under FDA product code MQV (Filler, Bone Void, Calcium Compound).
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