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FDA 510(k)

BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS

K-Number: K042517 · 2004-10-08

ApplicantLinvatec Biomaterials, Ltd.
Decision Date2004-10-08
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Biomaterials, Ltd.. It received FDA 510(k) clearance on 2004-10-08 under 510(k) number K042517. 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 BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS?

BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS is a medical device that received FDA 510(k) clearance on 2004-10-08. The listed applicant is Linvatec Biomaterials, Ltd.. The 510(k) number is K042517.

When did BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS receive FDA 510(k) clearance?

BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS received FDA 510(k) clearance on 2004-10-08, under 510(k) number K042517.

Who is the listed applicant for BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS?

The FDA 510(k) record lists Linvatec Biomaterials, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS?

The FDA product code for BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS is JEY.

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Other records listing Linvatec Biomaterials, Ltd. 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.

K042966DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218HK042295SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020K032447CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADEDK0319812.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445

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

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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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