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FDA 510(k)

BONE INJECTION GUN (B.I.G.)

K-Number: K062940 · 2006-12-22

ApplicantWaismed, Ltd.
Decision Date2006-12-22
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BONE INJECTION GUN (B.I.G.) is the device name listed in this FDA 510(k) record. The listed applicant is Waismed, Ltd.. It received FDA 510(k) clearance on 2006-12-22 under 510(k) number K062940. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONE INJECTION GUN (B.I.G.)?

BONE INJECTION GUN (B.I.G.) is a medical device that received FDA 510(k) clearance on 2006-12-22. The listed applicant is Waismed, Ltd.. The 510(k) number is K062940.

When did BONE INJECTION GUN (B.I.G.) receive FDA 510(k) clearance?

BONE INJECTION GUN (B.I.G.) received FDA 510(k) clearance on 2006-12-22, under 510(k) number K062940.

Who is the listed applicant for BONE INJECTION GUN (B.I.G.)?

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

What is the FDA product code for BONE INJECTION GUN (B.I.G.)?

The FDA product code for BONE INJECTION GUN (B.I.G.) is FMI.

Related Clinical Trials

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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Other records listing Waismed, Ltd. as applicant

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.

K211968NIO+ AdultK190538NIO-IK160805NIO-PK022415BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1STK981853BONE INJECTION GUN (B.I.G.) DEVICE

Related Devices (Code: FMI)

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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