Nuvasive Helix Acp System
FDA 510(k) K071329 · Nuvasive, Inc.
510(k) numberK071329
Submission
- Device name
- Nuvasive Helix Acp System
- Applicant
- Nuvasive, Inc.
San Diego, CA, US - Received
- May 11, 2007
- Decision date
- August 8, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Nuvasive Helix Acp System cleared by the FDA?
Nuvasive Helix Acp System (K071329) received a 510(k) decision of Substantially Equivalent on August 8, 2007, 89 days after the submission was received.
What is the product code of K071329?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.