Synergy 4.0 MM, 4.5 MM VLS Screws
FDA 510(k) K011437 · Interpore Cross Intl.
510(k) numberK011437
Submission
- Device name
- Synergy 4.0 MM, 4.5 MM VLS Screws
- Applicant
- Interpore Cross Intl.
Irvine, CA, US - Received
- May 10, 2001
- Decision date
- June 6, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 4.0 MM, 4.5 MM VLS Screws cleared by the FDA?
Synergy 4.0 MM, 4.5 MM VLS Screws (K011437) received a 510(k) decision of Substantially Equivalent on June 6, 2001, 27 days after the submission was received.
What is the product code of K011437?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.