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FDA 510(k)

CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM

K-Number: K895219 · 1989-09-12

ApplicantOrthopedic Systems, Inc.
Decision Date1989-09-12
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Systems, Inc.. It received FDA 510(k) clearance on 1989-09-12 under 510(k) number K895219. 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 CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM?

CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM is a medical device that received FDA 510(k) clearance on 1989-09-12. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K895219.

When did CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM receive FDA 510(k) clearance?

CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM received FDA 510(k) clearance on 1989-09-12, under 510(k) number K895219.

Who is the listed applicant for CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM?

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

What is the FDA product code for CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM?

The FDA product code for CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM is HWC. This falls under the Cardiovascular category.

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Related Devices (Code: HWC)

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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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