InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm)

FDA 510(k) K150322 · Pan Medical , Ltd.

Substantially Equivalent

510(k) numberK150322

Submission

Device name
InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm)
Applicant
Pan Medical , Ltd.
Gloucester, GB
Received
February 9, 2015
Decision date
March 6, 2015
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

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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More from Tecres S.P.A.

510(k)DeviceDecision
K16245313G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)NDN · Special 11/01/2016SE
K132620Inter V Kyphoplasty Catheter (Balloon Length: 0 MM), Interv Kyphoplasty Catheter…NDN · Traditional 04/16/2014SE

Questions and answers

When was InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm) cleared by the FDA?

InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm) (K150322) received a 510(k) decision of Substantially Equivalent on March 6, 2015, 25 days after the submission was received.

What is the product code of K150322?

The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.