2.5 MM Lactosorb Screws
FDA 510(k) K981666 · Biomet, Inc.
510(k) numberK981666
Submission
- Device name
- 2.5 MM Lactosorb Screws
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- May 11, 1998
- Decision date
- November 3, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was 2.5 MM Lactosorb Screws cleared by the FDA?
2.5 MM Lactosorb Screws (K981666) received a 510(k) decision of Substantially Equivalent on November 3, 1998, 176 days after the submission was received.
What is the product code of K981666?
The FDA product code is DZL – Screw, Fixation, Intraosseous, a Class II (moderate risk) device regulated under 21 CFR 872.4880.