FDA 510(k)

SONICWELD RX (RESORB-X)

K-Number: K080862 · 2008-07-21

Decision Date2008-07-21

Product CodeJEY

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

SONICWELD RX (RESORB-X) 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 2008-07-21 under 510(k) number K080862. 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 SONICWELD RX (RESORB-X)?

SONICWELD RX (RESORB-X) is a medical device that received FDA 510(k) clearance on 2008-07-21. The listed applicant is KLS-Martin L.P.. The 510(k) number is K080862.

When did SONICWELD RX (RESORB-X) receive FDA 510(k) clearance?

SONICWELD RX (RESORB-X) received FDA 510(k) clearance on 2008-07-21, under 510(k) number K080862.

Who is the listed applicant for SONICWELD RX (RESORB-X)?

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 SONICWELD RX (RESORB-X)?

The FDA product code for SONICWELD RX (RESORB-X) 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 K254162KLS Martin Ixos System K253660KLS Martin Pure Pectus 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.