DRG Orthohex SS Bone Screw
FDA 510(k) K013786 · Doctor'S Research Group, Inc.
510(k) numberK013786
Submission
- Device name
- DRG Orthohex SS Bone Screw
- Applicant
- Doctor'S Research Group, Inc.
Plymouth, CT, US - Received
- November 14, 2001
- Decision date
- December 17, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K990920 | DRG Titanium Bone PlateJEY · Traditional | 06/10/1999SE |
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Questions and answers
When was DRG Orthohex SS Bone Screw cleared by the FDA?
DRG Orthohex SS Bone Screw (K013786) received a 510(k) decision of Substantially Equivalent on December 17, 2001, 33 days after the submission was received.
What is the product code of K013786?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.