Synergy Adjustable Length Rod
FDA 510(k) K990057 · Interpore Cross Intl.
510(k) numberK990057
Submission
- Device name
- Synergy Adjustable Length Rod
- Applicant
- Interpore Cross Intl.
Irvine, CA, US - Received
- January 7, 1999
- Decision date
- June 28, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNI – Orthosis, Spinal Pedicle 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 Synergy Adjustable Length Rod cleared by the FDA?
Synergy Adjustable Length Rod (K990057) received a 510(k) decision of Substantially Equivalent on June 28, 1999, 172 days after the submission was received.
What is the product code of K990057?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.