Consulting Wallah › Device Explorer › Orthopaedic implants › Internal orthopaedic fixation system, plate/screw,
Device Explorer · FDA GUDID · GMDN 61688

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

A sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a se

US‑registered devices486in commercial distribution
Companies15labelers on GUDID
Single‑use98%of device records
Sterile96%labelled sterile
Prescription92%Rx‑only share
ShareLinkedIn

Share of device records

Acumed Llc23849%
Aurora Spine, Inc.5511%
Arthrosurface Incorporated439%
Zimmer Gmbh286%
Paragon 28, Inc.225%
Neosteo173%
Ascension Orthopedics, Inc.173%
Orthopedic Sciences Inc163%

Top labelers

CompanyDevicesShare
Acumed Llc23849%
Aurora Spine, Inc.5511%
Arthrosurface Incorporated439%
Zimmer Gmbh286%
Paragon 28, Inc.225%
Neosteo173%
Ascension Orthopedics, Inc.173%
Orthopedic Sciences Inc163%
Flower Orthopedics Corporation122%
Osteomed Llc112%
Globus Medical, Inc.82%
Conventus Orthopaedics, Inc.71%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Distal radius plate 7/3 holes,left, polyaxialDistal radius plate 7/3 holes,right, polyaxialTI WIN DF-plates 7/6 hole leftTI WIN DF-plate 7/6 hole rightmahe medical GmbHFlexitSystemDynamic SyndesmosisCable-Ready®NCB®OsteoMedPolyLock MidFootLow Profile Locking Plate, 8 HolesLow Profile Locking Plate, 7 HolesLow Profile Locking Plate, 6 HolesLow Profile Locking Plate, 5 HolesLow Profile Locking Plate, 4 Holes

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, bone275
HRSPlate, Fixation, Bone69
HWCScrew, fixation, bone67
PEKSpinous Process Plate54
HRSPLATE, FIXATION, BONE38
HWCScrew, Fixation, Bone30

GMDN & GCC registration

  • GMDN code 61688 · non‑implantable
  • Single‑use 98% · sterile 96% · Rx‑only 92% · 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

Length (Millimeter) · 91Lumen/Inner Diameter (Millimeter) · 44Angle (degree) · 16Height (Millimeter) · 10Outer Diameter (Millimeter) · 5

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

How many internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile products are registered in the US?

486 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile", from 15 companies. The largest labeler is Acumed Llc with 49% of records.

Which FDA product codes apply?

HRS (Plate, fixation, bone), HRS (Plate, Fixation, Bone), HWC (Screw, fixation, bone), PEK (Spinous Process Plate)

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.

How do I get quotes?

Add internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

Request quotes for Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying internal orthopaedic fixation system, plate/screw, for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

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.

Get quotes →