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FDA 510(k)

Monkey RingsTM External Fixation System

K-Number: K232838 · 2023-10-12

ApplicantParagon 28, Inc.
Decision Date2023-10-12
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Monkey RingsTM External Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28, Inc.. It received FDA 510(k) clearance on 2023-10-12 under 510(k) number K232838. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Monkey RingsTM External Fixation System?

Monkey RingsTM External Fixation System is a medical device that received FDA 510(k) clearance on 2023-10-12. The listed applicant is Paragon 28, Inc.. The 510(k) number is K232838.

When did Monkey RingsTM External Fixation System receive FDA 510(k) clearance?

Monkey RingsTM External Fixation System received FDA 510(k) clearance on 2023-10-12, under 510(k) number K232838.

Who is the listed applicant for Monkey RingsTM External Fixation System?

The FDA 510(k) record lists Paragon 28, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Monkey RingsTM External Fixation System?

The FDA product code for Monkey RingsTM External Fixation System is KTT.

Other records listing Paragon 28, Inc. 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.

K261121Megalodon Dynamic Compression SystemK262047Grappler Suture Anchor SystemK253886Grappler Suture Anchor PCFD Tether SystemK253591Phantom® Hindfoot TTC/TC Nail SystemK253613Monkey Rings External Ring Fixation SystemK252106External Fixation Mini Rail System

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Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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