Parallax Balloon Inflatable Bone TAMP-10 MM Balloon Parallax Balloon Inflatable Bone TAMP-15 MM Balloon Parallax Balloon
FDA 510(k) K122503 · Neuro Therm, Inc.
510(k) numberK122503
Submission
- Device name
- Parallax Balloon Inflatable Bone TAMP-10 MM Balloon Parallax Balloon Inflatable Bone TAMP-15 MM Balloon Parallax Balloon
- Applicant
- Neuro Therm, Inc.
Ashland, MA, US - Received
- August 16, 2012
- Decision date
- June 25, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDN – Cement, Bone, Vertebroplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3027
- Specialty
- Orthopedic
- Implant
- Yes
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| K221697 | Injection Pin (KIP(02031-02061) (03031-03061))NDN · Traditional | Slk Ortho, LLC | 03/03/2023SE |
| K223294 | SpineJack® Expansion KitNDN · Traditional | Stryker Instruments | 12/20/2022SE |
| K220131 | KYPHON VuE Bone CementNDN · Traditional | Tecres S.P.A. | 04/18/2022SE |
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Questions and answers
When was Parallax Balloon Inflatable Bone TAMP-10 MM Balloon Parallax Balloon Inflatable Bone TAMP-15 MM Balloon Parallax Balloon cleared by the FDA?
Parallax Balloon Inflatable Bone TAMP-10 MM Balloon Parallax Balloon Inflatable Bone TAMP-15 MM Balloon Parallax Balloon (K122503) received a 510(k) decision of Substantially Equivalent on June 25, 2013, 313 days after the submission was received.
What is the product code of K122503?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.