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FDA 510(k)

The Simple Locking Intramedullary (Slim) System

K-Number: K192710 · 2020-06-24

ApplicantPega Medical, Inc.
Decision Date2020-06-24
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The Simple Locking Intramedullary (Slim) System is a medical device manufactured by Pega Medical, Inc.. It received FDA 510(k) clearance on 2020-06-24 under approval number K192710. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Simple Locking Intramedullary (Slim) System?

The Simple Locking Intramedullary (Slim) System is a medical device that received FDA 510(k) clearance on 2020-06-24. It is manufactured by Pega Medical, Inc.. The 510(k) number is K192710.

When was The Simple Locking Intramedullary (Slim) System approved by the FDA?

The Simple Locking Intramedullary (Slim) System received FDA 510(k) clearance on 2020-06-24, under approval number K192710.

What company makes The Simple Locking Intramedullary (Slim) System?

The Simple Locking Intramedullary (Slim) System is manufactured by Pega Medical, Inc..

What is the FDA product code for The Simple Locking Intramedullary (Slim) System?

The FDA product code for The Simple Locking Intramedullary (Slim) System is HSB.

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Other Devices by Pega Medical, Inc.

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Related Devices (Code: HSB)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated

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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