DRG Quickmix
FDA 510(k) K011736 · Doctor'S Research Group, Inc.
510(k) numberK011736
Submission
- Device name
- DRG Quickmix
- Applicant
- Doctor'S Research Group, Inc.
Wolcott, CT, US - Received
- June 5, 2001
- Decision date
- January 30, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K251959 | TnR Cranial ImplantGXP · Traditional | T&R BIOFAB CO., Ltd. | 07/30/2026SE |
| K261265 | Permatage XT Settable Bone PuttyGXP · Special | Orthocon, Inc. | 06/15/2026SE |
| K253732 | Permatage Flowable, Settable Bone PasteGXP · Traditional | Orthocon, Inc. | 03/13/2026SE |
| K253854 | MONTAGE XT Cranial CementGXP · Special | Orthocon, Inc. | 01/02/2026SE |
| K241027 | Permatage Settable Bone PuttyGXP · Traditional | Orthocon, Inc. | 09/26/2024SE |
| K232771 | Montage Flowable Settable, Resorbable Bone PasteGXP · Traditional | Orthocon, Inc. | 02/16/2024SE |
| K231475 | MONTAGE-QS Settable, Resorbable Bone PuttyGXP · Traditional | Orthocon, Inc. | 10/12/2023SE |
| K221933 | MONTAGE Settable, Resorbable Bone PuttyGXP · Traditional | Orthocon, Inc. | 01/13/2023SE |
| K182742 | Db-CmfGXP · Traditional | Dimensional Bioceramics, LLC | 06/20/2019SE |
| K162864 | OsteoVation ImpactGXP · Traditional | Skeletal Kinetics, LLC | 01/13/2017SE |
More from Skeletal Kinetics, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K051487 | DRG Laryngeal Augmentation Implant DeviceKHJ · Traditional | 12/22/2005SE |
| K041018 | DRG SoftreleaseHHT · Traditional | 10/18/2004SE |
| K012535 | DRG Disposable Vaginal SpeculumHIB · Traditional | 03/01/2002SE |
| K012003 | DRG Reaction Chamber/Safety TipHEI · Traditional | 02/12/2002SE |
| K013786 | DRG Orthohex SS Bone ScrewHWC · Traditional | 12/17/2001SE |
| K002047 | DRG Puretone Stethoscope with DRG Antimicrobial, Stethoscope Diaphragm, Model…DQD · Traditional | 11/22/2000SE |
| K991714 | DRG Conventional Electronic Digital Stethoscope, Model Echop 200-00DQD · Traditional | 12/10/1999SE |
| K990212 | Lockjaw 15 Minute Intermaxillary Fixation System,Model LJ100-00DYX · Traditional | 09/14/1999SE |
| K990920 | DRG Titanium Bone PlateJEY · Traditional | 06/10/1999SE |
| K981881 | DRG Sherlock MF Bone Screw, Cocrmo Self-Tapping, Ti Alloy Self-Tapping/Self Drilling…DZL · Traditional | 12/02/1998SE |
Questions and answers
When was DRG Quickmix cleared by the FDA?
DRG Quickmix (K011736) received a 510(k) decision of Substantially Equivalent on January 30, 2002, 239 days after the submission was received.
What is the product code of K011736?
The FDA product code is GXP – Methyl Methacrylate For Cranioplasty, a Class II (moderate risk) device regulated under 21 CFR 882.5300.