Acid Etched Lag Screws
FDA 510(k) K070955 · Biomet Orthopedics, Inc.
510(k) numberK070955
Submission
- Device name
- Acid Etched Lag Screws
- Applicant
- Biomet Orthopedics, Inc.
Warsaw, IN, US - Received
- April 5, 2007
- Decision date
- October 12, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Acid Etched Lag Screws cleared by the FDA?
Acid Etched Lag Screws (K070955) received a 510(k) decision of Substantially Equivalent on October 12, 2007, 190 days after the submission was received.
What is the product code of K070955?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.