Zodiac Adjustable Bridges, Models 11-20XX,11-25XX,11-30XX,11-35XX
FDA 510(k) K061321 · Alphatec Spine, Inc.
510(k) numberK061321
Submission
- Device name
- Zodiac Adjustable Bridges, Models 11-20XX,11-25XX,11-30XX,11-35XX
- Applicant
- Alphatec Spine, Inc.
Carlsbad, CA, US - Received
- May 11, 2006
- Decision date
- July 7, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNH – Orthosis, Spondylolisthesis Spinal Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Zodiac Adjustable Bridges, Models 11-20XX,11-25XX,11-30XX,11-35XX cleared by the FDA?
Zodiac Adjustable Bridges, Models 11-20XX,11-25XX,11-30XX,11-35XX (K061321) received a 510(k) decision of Substantially Equivalent on July 7, 2006, 57 days after the submission was received.
What is the product code of K061321?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.