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FDA 510(k)

STAPLETAC BONE ANCHOR SYSTEM

K-Number: K992277 · 1999-07-30

ApplicantInfluence, Inc.
Decision Date1999-07-30
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STAPLETAC BONE ANCHOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Influence, Inc.. It received FDA 510(k) clearance on 1999-07-30 under 510(k) number K992277. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAPLETAC BONE ANCHOR SYSTEM?

STAPLETAC BONE ANCHOR SYSTEM is a medical device that received FDA 510(k) clearance on 1999-07-30. The listed applicant is Influence, Inc.. The 510(k) number is K992277.

When did STAPLETAC BONE ANCHOR SYSTEM receive FDA 510(k) clearance?

STAPLETAC BONE ANCHOR SYSTEM received FDA 510(k) clearance on 1999-07-30, under 510(k) number K992277.

Who is the listed applicant for STAPLETAC BONE ANCHOR SYSTEM?

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

What is the FDA product code for STAPLETAC BONE ANCHOR SYSTEM?

The FDA product code for STAPLETAC BONE ANCHOR SYSTEM is HWC. This falls under the Cardiovascular category.

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Other records listing Influence, Inc. 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.

K981677REPOSE BONE SCREW SYSTEMK991792CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBEK991122CRYO-MONO CRYOGRNIC SYSTEMK990160MICROTAC-BONE ANCHOR SYSTEMK990095STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEMK983325IN-PROBE II URODYNAMIC SYSTEM

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Related Devices (Code: HWC)

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Official Source

View on FDA Database →

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

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