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FDA 510(k)

INTERMEDICS BONE SCREW

K-Number: K850770 · 1985-04-19

ApplicantIntermedics Orthopedics
Decision Date1985-04-19
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTERMEDICS BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1985-04-19 under 510(k) number K850770. 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 INTERMEDICS BONE SCREW?

INTERMEDICS BONE SCREW is a medical device that received FDA 510(k) clearance on 1985-04-19. The listed applicant is Intermedics Orthopedics. The 510(k) number is K850770.

When did INTERMEDICS BONE SCREW receive FDA 510(k) clearance?

INTERMEDICS BONE SCREW received FDA 510(k) clearance on 1985-04-19, under 510(k) number K850770.

Who is the listed applicant for INTERMEDICS BONE SCREW?

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

What is the FDA product code for INTERMEDICS BONE SCREW?

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

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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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