Sure-Lok C Extended Tab Pedicle Screw System
FDA 510(k) K141397 · Precision Spine, Inc.
510(k) numberK141397
Submission
- Device name
- Sure-Lok C Extended Tab Pedicle Screw System
- Applicant
- Precision Spine, Inc.
Pear, MS, US - Received
- May 28, 2014
- Decision date
- June 26, 2014
- 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 Sure-Lok C Extended Tab Pedicle Screw System cleared by the FDA?
Sure-Lok C Extended Tab Pedicle Screw System (K141397) received a 510(k) decision of Substantially Equivalent on June 26, 2014, 29 days after the submission was received.
What is the product code of K141397?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.