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FDA 510(k)

AUTO-DRIVE BONE SCREW

K-Number: K974785 · 1998-03-18

ApplicantOsteomed Corp.
Decision Date1998-03-18
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AUTO-DRIVE BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed Corp.. It received FDA 510(k) clearance on 1998-03-18 under 510(k) number K974785. 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 AUTO-DRIVE BONE SCREW?

AUTO-DRIVE BONE SCREW is a medical device that received FDA 510(k) clearance on 1998-03-18. The listed applicant is Osteomed Corp.. The 510(k) number is K974785.

When did AUTO-DRIVE BONE SCREW receive FDA 510(k) clearance?

AUTO-DRIVE BONE SCREW received FDA 510(k) clearance on 1998-03-18, under 510(k) number K974785.

Who is the listed applicant for AUTO-DRIVE BONE SCREW?

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

What is the FDA product code for AUTO-DRIVE BONE SCREW?

The FDA product code for AUTO-DRIVE BONE SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Osteomed Corp. 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.

K022277OSTEOMED CRANIAL FLAP FIXATION SYSTEMK022887INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMK022886METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMK0232601.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEMK013618INTRAORAL MANDIBULAR DISTRACTION SYSTEMK021618OSA RIGID INTERNAL FIXATION 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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