Romeo 2 Pad Posterior Axial Device
FDA 510(k) K141508 · Spineart
510(k) numberK141508
Submission
- Device name
- Romeo 2 Pad Posterior Axial Device
- Applicant
- Spineart
Geneva, CH - Received
- June 6, 2014
- Decision date
- August 21, 2014
- 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 Romeo 2 Pad Posterior Axial Device cleared by the FDA?
Romeo 2 Pad Posterior Axial Device (K141508) received a 510(k) decision of Substantially Equivalent on August 21, 2014, 76 days after the submission was received.
What is the product code of K141508?
The FDA product code is PEK – Spinous Process Plate, a Class II (moderate risk) device regulated under 21 CFR 888.3050.