Mastergraft Putty
FDA 510(k) K081784 · Medtronic Sofamor Danek
510(k) numberK081784
Submission
- Device name
- Mastergraft Putty
- Applicant
- Medtronic Sofamor Danek
Memphis, TN, US - Received
- June 24, 2008
- Decision date
- September 17, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYC – Bone Grafting Material, Synthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3930
- Specialty
- Dental
- Implant
- Yes
A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.
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| K213260 | CMFlexTMLYC · Traditional | Dimension Inx Corp. | 12/30/2022SE |
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| K201546 | OsOpia Synthetic Bone Void FillerLYC · Traditional | Revisios BV | 10/02/2020SE |
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| 510(k) | Device | Decision |
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| K243706 | Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMQV · Traditional | 01/17/2025SE |
| K230716 | Robotic Graft Delivery InstrumentsOLO · Traditional | 07/18/2023SE |
| K212428 | Centerpiece Plate Fixation SystemNQW · Traditional | 12/13/2021SE |
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| K172199 | ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…MAX · Traditional | 09/19/2017SE |
| K171031 | CRESCENT Spinal SystemMAX · Special | 07/06/2017SE |
| K171468 | FUSE Spinal SystemMAX · Special | 06/13/2017SE |
| K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…NKB · Traditional | 05/11/2017SE |
Questions and answers
When was Mastergraft Putty cleared by the FDA?
Mastergraft Putty (K081784) received a 510(k) decision of Substantially Equivalent on September 17, 2008, 85 days after the submission was received.
What is the product code of K081784?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.