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FDA 510(k)

TIBIA ORTHONAIL

K-Number: K955761 · 1996-03-13

ApplicantOrthologic Corp.
Decision Date1996-03-13
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TIBIA ORTHONAIL is the device name listed in this FDA 510(k) record. The listed applicant is Orthologic Corp.. It received FDA 510(k) clearance on 1996-03-13 under 510(k) number K955761. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIBIA ORTHONAIL?

TIBIA ORTHONAIL is a medical device that received FDA 510(k) clearance on 1996-03-13. The listed applicant is Orthologic Corp.. The 510(k) number is K955761.

When did TIBIA ORTHONAIL receive FDA 510(k) clearance?

TIBIA ORTHONAIL received FDA 510(k) clearance on 1996-03-13, under 510(k) number K955761.

Who is the listed applicant for TIBIA ORTHONAIL?

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

What is the FDA product code for TIBIA ORTHONAIL?

The FDA product code for TIBIA ORTHONAIL is HSB.

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 Orthologic Corp. 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.

K952739ORTHONAILK931697FIXATION PIN

Related Devices (Code: HSB)

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.

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbHK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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