Consulting Wallah › Device Explorer › Orthopaedic implants › Growth-correction orthopaedic fixation plate kit
Device Explorer · FDA GUDID · GMDN 44896

Growth-correction orthopaedic fixation plate kit

A collection of implantable devices used to redirect the angle of growth of long bones in paediatric patients where the growth plates (epiphysial cartilage) are not fused, to allow for the gradual correction of congenital or acquired deformities (e.g., valgus,

US‑registered devices501in commercial distribution
Companies4labelers on GUDID
Single‑use68%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Orthopediatrics Corp.28356%
Orthofix Us Llc20942%
Orthopediatrics Canada Ulc82%
Medline Industries, Inc.10%

Top labelers

CompanyDevicesShare
Orthopediatrics Corp.28356%
Orthofix Us Llc20942%
Orthopediatrics Canada Ulc82%
Medline Industries, Inc.10%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

GIRO GROWTH MODULATION SYSTEMOrthoPediatrics PediFoot Deformity Correction SyPediLoc TibiaLocking Proximal FemurLocking Proximal Femur Plate SystemPediPlateLocking Proximal Femur Plate System (LPF)SCFE ScrewNAVIGATED INSTRUMENTSNAVIGATED INSTRUMENTS;PHOENIX SFSNAVIGATED INSTRUMENTS;FIREBIRD NXGPROVIEWONYX;PROVIEWPENDING

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
HRSPLATE, FIXATION, BONE212
OBTPlate, Bone, Growth Control, Pediatric, Epiphysiodesis152
HRSPlate, fixation, bone102
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT71
OLOOrthopedic stereotaxic instrument52
GADRETRACTOR44

GMDN & GCC registration

  • GMDN code 44896 · non‑implantable
  • Single‑use 68% · sterile 0% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Lumen/Inner Diameter (Millimeter) · 4

Use these as the dimensions to specify in a tender line.

How many growth-correction orthopaedic fixation plate kit products are registered in the US?

501 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Growth-correction orthopaedic fixation plate kit", from 4 companies. The largest labeler is Orthopediatrics Corp. with 56% of records.

Which FDA product codes apply?

HRS (PLATE, FIXATION, BONE), OBT (Plate, Bone, Growth Control, Pediatric, Epiphysiodesis), HRS (Plate, fixation, bone), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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