Apex Universal Drive System
FDA 510(k) K964548 · Linvatec Corp.
510(k) numberK964548
Submission
- Device name
- Apex Universal Drive System
- Applicant
- Linvatec Corp.
Largo, FL, US - Received
- November 13, 1996
- Decision date
- January 17, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4250
- Specialty
- Ear, Nose, Throat
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Questions and answers
When was Apex Universal Drive System cleared by the FDA?
Apex Universal Drive System (K964548) received a 510(k) decision of Substantially Equivalent on January 17, 1997, 65 days after the submission was received.
What is the product code of K964548?
The FDA product code is ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, a Class II (moderate risk) device regulated under 21 CFR 874.4250.