FDA 510(k)

MICRO OSTEOSYNTHESIS SYSTEM (1.0)

K-Number: K944561 · 1994-10-18

Decision Date1994-10-18

Product CodeJEY

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

MICRO OSTEOSYNTHESIS SYSTEM (1.0) is the device name listed in this FDA 510(k) record. The listed applicant is KLS-Martin L.P.. It received FDA 510(k) clearance on 1994-10-18 under 510(k) number K944561. 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 MICRO OSTEOSYNTHESIS SYSTEM (1.0)?

MICRO OSTEOSYNTHESIS SYSTEM (1.0) is a medical device that received FDA 510(k) clearance on 1994-10-18. The listed applicant is KLS-Martin L.P.. The 510(k) number is K944561.

When did MICRO OSTEOSYNTHESIS SYSTEM (1.0) receive FDA 510(k) clearance?

MICRO OSTEOSYNTHESIS SYSTEM (1.0) received FDA 510(k) clearance on 1994-10-18, under 510(k) number K944561.

Who is the listed applicant for MICRO OSTEOSYNTHESIS SYSTEM (1.0)?

The FDA 510(k) record lists KLS-Martin L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICRO OSTEOSYNTHESIS SYSTEM (1.0)?

The FDA product code for MICRO OSTEOSYNTHESIS SYSTEM (1.0) is JEY.

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Other records listing KLS-Martin L.P. as applicant

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions K253660KLS Martin Pure Pectus System K254162KLS Martin Ixos System K250988KLS Martin Pure Pectus System K250865KLS Martin IPS Forearm System K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

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Related Devices (Code: JEY)

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 Corporation K253373Southern 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 OY K241314KLS 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.