Timx Low Back System Titanium MX Rod Based Low Back System
FDA 510(k) K981714 · Acromed Corp.
510(k) numberK981714
Submission
- Device name
- Timx Low Back System Titanium MX Rod Based Low Back System
- Applicant
- Acromed Corp.
Cleveland, OH, US - Received
- May 15, 1998
- Decision date
- June 30, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Timx Low Back System Titanium MX Rod Based Low Back System cleared by the FDA?
Timx Low Back System Titanium MX Rod Based Low Back System (K981714) received a 510(k) decision of Substantially Equivalent on June 30, 1998, 46 days after the submission was received.
What is the product code of K981714?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.