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FDA 510(k)

ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE

K-Number: K011087 · 2001-09-19

ApplicantOrthovita, Inc.
Decision Date2001-09-19
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Orthovita, Inc.. It received FDA 510(k) clearance on 2001-09-19 under 510(k) number K011087. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE?

ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE is a medical device that received FDA 510(k) clearance on 2001-09-19. The listed applicant is Orthovita, Inc.. The 510(k) number is K011087.

When did ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE receive FDA 510(k) clearance?

ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE received FDA 510(k) clearance on 2001-09-19, under 510(k) number K011087.

Who is the listed applicant for ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE?

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

What is the FDA product code for ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE?

The FDA product code for ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE is FMF.

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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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