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FDA 510(k)

TELOS DISTAL TARGETING DEVICE

K-Number: K880381 · 1988-03-15

ApplicantAustin Assoc.
Decision Date1988-03-15
Product CodeHXY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TELOS DISTAL TARGETING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Austin Assoc.. It received FDA 510(k) clearance on 1988-03-15 under 510(k) number K880381. The device is classified under product code HXY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TELOS DISTAL TARGETING DEVICE?

TELOS DISTAL TARGETING DEVICE is a medical device that received FDA 510(k) clearance on 1988-03-15. The listed applicant is Austin Assoc.. The 510(k) number is K880381.

When did TELOS DISTAL TARGETING DEVICE receive FDA 510(k) clearance?

TELOS DISTAL TARGETING DEVICE received FDA 510(k) clearance on 1988-03-15, under 510(k) number K880381.

Who is the listed applicant for TELOS DISTAL TARGETING DEVICE?

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

What is the FDA product code for TELOS DISTAL TARGETING DEVICE?

The FDA product code for TELOS DISTAL TARGETING DEVICE is HXY.

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Related Devices (Code: HXY)

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.

K923776BENDEREV DRILL GUIDENeimark Labs, Inc.K892904MITEK DRILL GUIDEMitek Surgical Products, Inc.K880264BONE SUTURE FIXATION DEVICEOrthopedic Systems, Inc.K880046HASTING FINGER FIXATOR INSTRUMENTSBuckman Co., Inc.K831043ANDREWS REMOTE CHUCK DRILLOrthopedic Systems, Inc.K770204CEMENT EXTRACTOR DRILLDepuy, Inc.

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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