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FDA 510(k)

INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM

K-Number: K010351 · 2001-03-15

ApplicantInion , Ltd.
Decision Date2001-03-15
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Inion , Ltd.. It received FDA 510(k) clearance on 2001-03-15 under 510(k) number K010351. 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 INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM?

INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2001-03-15. The listed applicant is Inion , Ltd.. The 510(k) number is K010351.

When did INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM receive FDA 510(k) clearance?

INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM received FDA 510(k) clearance on 2001-03-15, under 510(k) number K010351.

Who is the listed applicant for INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM?

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

What is the FDA product code for INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM?

The FDA product code for INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM is JEY.

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Other records listing Inion , 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.

K071810INION SPINAL GRAFT CONTAINMENT SYSTEMK063410INION CPS/OTPS FREEDOMPLATEK062617MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEMK060393INION HEXALON BIODEGRADABLE ACL/PCL SCREWK051821INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEMK052624INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE

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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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