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FDA 510(k)

BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM

K-Number: K011390 · 2001-06-06

ApplicantDisc-O-Tech Medical Technologies, Ltd.
Decision Date2001-06-06
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Disc-O-Tech Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2001-06-06 under 510(k) number K011390. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM?

BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2001-06-06. The listed applicant is Disc-O-Tech Medical Technologies, Ltd.. The 510(k) number is K011390.

When did BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM receive FDA 510(k) clearance?

BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM received FDA 510(k) clearance on 2001-06-06, under 510(k) number K011390.

Who is the listed applicant for BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM?

The FDA 510(k) record lists Disc-O-Tech Medical Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM?

The FDA product code for BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM is MBI.

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Related Devices (Code: MBI)

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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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