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FDA 510(k)

BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM

K-Number: K982139 · 1998-09-15

ApplicantBionx Implants, Inc.
Decision Date1998-09-15
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bionx Implants, Inc.. It received FDA 510(k) clearance on 1998-09-15 under 510(k) number K982139. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM?

BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1998-09-15. The listed applicant is Bionx Implants, Inc.. The 510(k) number is K982139.

When did BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM receive FDA 510(k) clearance?

BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM received FDA 510(k) clearance on 1998-09-15, under 510(k) number K982139.

Who is the listed applicant for BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM?

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

What is the FDA product code for BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM?

The FDA product code for BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM is JEY.

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Other records listing Bionx Implants, 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.

K023022NUGEN FX SCREWK011569BIOSORBFX O/M 2.0/2/4 SYSTEMK013546MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214K013057BIOCUFF,C, MODELS 236018, 236028, 236036K012334CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116K010983PLLA PIN

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Related Devices (Code: JEY)

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.

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsKLS-Martin L.P.K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical CorporationK253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OYK241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin 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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