Neotis; Neotis 50

FDA 510(k) K130953 · Sbm Sciences For Bio Materials

Substantially Equivalent

510(k) numberK130953

Submission

Device name
Neotis; Neotis 50
Applicant
Sbm Sciences For Bio Materials
Lourdes, FR
Received
April 5, 2013
Decision date
July 15, 2013
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MQV – Filler, Bone Void, Calcium Compound
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3045
Specialty
Orthopedic
Implant
Yes

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Questions and answers

When was Neotis; Neotis 50 cleared by the FDA?

Neotis; Neotis 50 (K130953) received a 510(k) decision of Substantially Equivalent on July 15, 2013, 101 days after the submission was received.

What is the product code of K130953?

The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.