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FDA 510(k)

KLSA MARTIN HAND DISTRACTOR

K-Number: K042066 · 2004-08-25

ApplicantKLS-Martin L.P.
Decision Date2004-08-25
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KLSA MARTIN HAND DISTRACTOR 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 2004-08-25 under 510(k) number K042066. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KLSA MARTIN HAND DISTRACTOR?

KLSA MARTIN HAND DISTRACTOR is a medical device that received FDA 510(k) clearance on 2004-08-25. The listed applicant is KLS-Martin L.P.. The 510(k) number is K042066.

When did KLSA MARTIN HAND DISTRACTOR receive FDA 510(k) clearance?

KLSA MARTIN HAND DISTRACTOR received FDA 510(k) clearance on 2004-08-25, under 510(k) number K042066.

Who is the listed applicant for KLSA MARTIN HAND DISTRACTOR?

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 KLSA MARTIN HAND DISTRACTOR?

The FDA product code for KLSA MARTIN HAND DISTRACTOR is JEC.

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Other records listing KLS-Martin L.P. 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.

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsK254162KLS Martin Ixos SystemK253660KLS Martin Pure Pectus SystemK250988KLS Martin Pure Pectus SystemK250865KLS Martin IPS Forearm SystemK252573KLS 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

View all 75 devices →

Related Devices (Code: JEC)

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.

K203605SteriTrakArbutus Medical, Inc.K193256Anjon Bremer Halo SystemAnjon Holdings, LLCK192465DigiFix Sterile KitVirak Orthopedics, LLCK181192PIP FixHand Biomechanics Lab, Inc.K171863Anjon Bremer Halo SystemAnjon Holdings, LLCK163028Medline ReNewal Reprocessed Stryker External Fixation DevicesSurgical Instrument Service and Savings, Inc.

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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