DRG Sherlock MF Bone Screw, Cocrmo Self-Tapping, Ti Alloy Self-Tapping/Self Drilling, Cocrmo Self-Tapping/ Self Drilling
FDA 510(k) K981881 · Doctor'S Research Group, Inc.
510(k) numberK981881
Submission
- Device name
- DRG Sherlock MF Bone Screw, Cocrmo Self-Tapping, Ti Alloy Self-Tapping/Self Drilling, Cocrmo Self-Tapping/ Self Drilling
- Applicant
- Doctor'S Research Group, Inc.
Wolcott, CT, US - Received
- May 28, 1998
- Decision date
- December 2, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was DRG Sherlock MF Bone Screw, Cocrmo Self-Tapping, Ti Alloy Self-Tapping/Self Drilling, Cocrmo Self-Tapping/ Self Drilling cleared by the FDA?
DRG Sherlock MF Bone Screw, Cocrmo Self-Tapping, Ti Alloy Self-Tapping/Self Drilling, Cocrmo Self-Tapping/ Self Drilling (K981881) received a 510(k) decision of Substantially Equivalent on December 2, 1998, 188 days after the submission was received.
What is the product code of K981881?
The FDA product code is DZL – Screw, Fixation, Intraosseous, a Class II (moderate risk) device regulated under 21 CFR 872.4880.