Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Guided Growth Plate System Plus

K-Number: K172183 · 2018-01-09

ApplicantOrthofix Srl
Decision Date2018-01-09
Product CodeOBT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Guided Growth Plate System Plus is a medical device manufactured by Orthofix Srl. It received FDA 510(k) clearance on 2018-01-09 under approval number K172183. The device is classified under product code OBT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Guided Growth Plate System Plus?

Guided Growth Plate System Plus is a medical device that received FDA 510(k) clearance on 2018-01-09. It is manufactured by Orthofix Srl. The 510(k) number is K172183.

When was Guided Growth Plate System Plus approved by the FDA?

Guided Growth Plate System Plus received FDA 510(k) clearance on 2018-01-09, under approval number K172183.

What company makes Guided Growth Plate System Plus?

Guided Growth Plate System Plus is manufactured by Orthofix Srl.

What is the FDA product code for Guided Growth Plate System Plus?

The FDA product code for Guided Growth Plate System Plus is OBT.

Related Clinical Trials

NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT07382674 Zesty Exercise System for Therapeutic Engagement RECRUITING NCT07607899 Virtual Reality for Pain and Well-Being in Older Adults NOT_YET_RECRUITING NCT06253858 Ultrasound (US) Guided External Ventricular Catheter Placement RECRUITING NCT06861309 Placental Imaging Techniques RECRUITING NCT05225935 Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia COMPLETED

Related PubMed Literature

PMID: 42184430 Navigation-guided endoscopic transcerebellar approach for cyst fenestration of a dorsal brainstem lesion: illustrative case. Journal of neurosurgery. Case lessons (2026) PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025)

Other Devices by Orthofix Srl

K153233Galaxy UNYCO System K173458ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System K173051Orthofix MJ-FLEX THE NEW METAIZEAU NAIL K170146Galaxy UNYCO System K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0 K161466ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System

View all 23 devices →

Related Devices (Code: OBT)

K180624Guided Growth Plate System PlusOrthofix Srl K182704WishBone Guided Growth SystemWishbone Medical K220190The GIRO Growth Modulation SystemPega Medical, 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.

↑