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FDA 510(k)

RONGUER-ORTHOPEDIC

K-Number: K890166 · 1989-02-13

ApplicantDhason Brothers, Inc.
Decision Date1989-02-13
Product CodeLXH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RONGUER-ORTHOPEDIC is the device name listed in this FDA 510(k) record. The listed applicant is Dhason Brothers, Inc.. It received FDA 510(k) clearance on 1989-02-13 under 510(k) number K890166. The device is classified under product code LXH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RONGUER-ORTHOPEDIC?

RONGUER-ORTHOPEDIC is a medical device that received FDA 510(k) clearance on 1989-02-13. The listed applicant is Dhason Brothers, Inc.. The 510(k) number is K890166.

When did RONGUER-ORTHOPEDIC receive FDA 510(k) clearance?

RONGUER-ORTHOPEDIC received FDA 510(k) clearance on 1989-02-13, under 510(k) number K890166.

Who is the listed applicant for RONGUER-ORTHOPEDIC?

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

What is the FDA product code for RONGUER-ORTHOPEDIC?

The FDA product code for RONGUER-ORTHOPEDIC is LXH.

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Other records listing Dhason Brothers, 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.

K890156IMPACTOR FOR FEMORAL HEADK890162EXTRACTOR FOR AUSTIN MOORE FEMORAL HEADK890165FORCEPS-ORTHOPEDICK890164HUDSON BRACE W/BURRSK890168RETRACTOR, SELF-RETAININGK890161THOMPSON TYPE RASP W/TOMMY BAR

View all 14 devices →

Related Devices (Code: LXH)

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.

K192873SX-One MicroKnifeSonex Health, Inc.K101609SELF RETAINING SOFT TISSUE RETRACTORKoros USA, Inc.K001507MICROPERFORATION INSTRUMENTSmith & Nephew, Inc.K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMOrthopedic Systems, Inc.K943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYOrthomet, Inc.K944188SPINAL MARKERLeibinger L.P.

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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