Affix Spinous Process Plate System
FDA 510(k) K131238 · Nuvasive, Inc.
510(k) numberK131238
Submission
- Device name
- Affix Spinous Process Plate System
- Applicant
- Nuvasive, Inc.
San Diego, CA, US - Received
- May 1, 2013
- Decision date
- July 2, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PEK – Spinous Process Plate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3050
- Specialty
- Orthopedic
- Implant
- Yes
A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and…
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Questions and answers
When was Affix Spinous Process Plate System cleared by the FDA?
Affix Spinous Process Plate System (K131238) received a 510(k) decision of Substantially Equivalent on July 2, 2013, 62 days after the submission was received.
What is the product code of K131238?
The FDA product code is PEK – Spinous Process Plate, a Class II (moderate risk) device regulated under 21 CFR 888.3050.