13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)

FDA 510(k) K162453 · Pan Medical , Ltd.

Substantially Equivalent

510(k) numberK162453

Submission

Device name
13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)
Applicant
Pan Medical , Ltd.
Gloucester, GB
Received
September 1, 2016
Decision date
November 1, 2016
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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K221697Injection Pin (KIP(02031-02061) (03031-03061))NDN · Traditional Slk Ortho, LLC03/03/2023SE
K223294SpineJack® Expansion KitNDN · Traditional Stryker Instruments12/20/2022SE
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More from Tecres S.P.A.

510(k)DeviceDecision
K150322InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter…NDN · Special 03/06/2015SE
K132620Inter V Kyphoplasty Catheter (Balloon Length: 0 MM), Interv Kyphoplasty Catheter…NDN · Traditional 04/16/2014SE

Questions and answers

When was 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) cleared by the FDA?

13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) (K162453) received a 510(k) decision of Substantially Equivalent on November 1, 2016, 61 days after the submission was received.

What is the product code of K162453?

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