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FDA 510(k)

NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT

K-Number: K112773 · 2011-10-14

ApplicantNovabone Products, LLC
Decision Date2011-10-14
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Novabone Products, LLC. It received FDA 510(k) clearance on 2011-10-14 under 510(k) number K112773. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT?

NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT is a medical device that received FDA 510(k) clearance on 2011-10-14. The listed applicant is Novabone Products, LLC. The 510(k) number is K112773.

When did NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT receive FDA 510(k) clearance?

NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT received FDA 510(k) clearance on 2011-10-14, under 510(k) number K112773.

Who is the listed applicant for NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT?

The FDA 510(k) record lists Novabone Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT?

The FDA product code for NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT is MQV.

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Other records listing Novabone Products, LLC as applicant

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K242299NovaBone Putty - Synthetic Bioactive Bone GraftK240404NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)K220498NovoGen Wound MatrixK163310NovaBone IRMK112428NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFTK110925NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT

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Related Devices (Code: MQV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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