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FDA 510(k)

CASF CANCELLOUS BONE SCREW, BT650

K-Number: K882934 · 1988-10-13

ApplicantTerray Manufacturing, Inc.
Decision Date1988-10-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CASF CANCELLOUS BONE SCREW, BT650 is the device name listed in this FDA 510(k) record. The listed applicant is Terray Manufacturing, Inc.. It received FDA 510(k) clearance on 1988-10-13 under 510(k) number K882934. 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 CASF CANCELLOUS BONE SCREW, BT650?

CASF CANCELLOUS BONE SCREW, BT650 is a medical device that received FDA 510(k) clearance on 1988-10-13. The listed applicant is Terray Manufacturing, Inc.. The 510(k) number is K882934.

When did CASF CANCELLOUS BONE SCREW, BT650 receive FDA 510(k) clearance?

CASF CANCELLOUS BONE SCREW, BT650 received FDA 510(k) clearance on 1988-10-13, under 510(k) number K882934.

Who is the listed applicant for CASF CANCELLOUS BONE SCREW, BT650?

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

What is the FDA product code for CASF CANCELLOUS BONE SCREW, BT650?

The FDA product code for CASF CANCELLOUS BONE SCREW, BT650 is HWC. This falls under the Cardiovascular category.

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Other records listing Terray Manufacturing, Inc. as applicant

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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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