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FDA 510(k)

BONE SUTURE FIXATION DEVICE

K-Number: K880264 · 1988-03-23

ApplicantOrthopedic Systems, Inc.
Decision Date1988-03-23
Product CodeHXY
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

BONE SUTURE FIXATION DEVICE 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 1988-03-23 under 510(k) number K880264. The device is classified under product code HXY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the BONE SUTURE FIXATION DEVICE?

BONE SUTURE FIXATION DEVICE is a medical device that received FDA 510(k) clearance on 1988-03-23. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K880264.

When did BONE SUTURE FIXATION DEVICE receive FDA 510(k) clearance?

BONE SUTURE FIXATION DEVICE received FDA 510(k) clearance on 1988-03-23, under 510(k) number K880264.

Who is the listed applicant for BONE SUTURE FIXATION DEVICE?

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 BONE SUTURE FIXATION DEVICE?

The FDA product code for BONE SUTURE FIXATION DEVICE is HXY.

Related Clinical Trials

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.

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Other records listing Orthopedic Systems, Inc. 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.

K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMK920256SPINE MOTION ANALYZER WITH EMGK910736JACKSON MULTIPURPOSE OPERATING TABLEK910031PARK CITY SHOULDER POSITIONERK903938C FIT CUPK892503NUFFIELD TOTAL KNEE

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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.K880381TELOS DISTAL TARGETING DEVICEAustin Assoc.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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