Consulting Wallah › Device Explorer › Other devices › Orthopaedic bone staple, non-adjustable, non-steri
Device Explorer · FDA GUDID · GMDN 61668

Orthopaedic bone staple, non-adjustable, non-sterile

A non-sterile, non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skelet

US‑registered devices69in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile35%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Fusion Orthopedics, Llc3652%
Vilex Llc2232%
Cpm Medical Consultants, Llc69%
Biomet Orthopedics, Llc46%
Exactech, Inc.11%

Top labelers

CompanyDevicesShare
Fusion Orthopedics, Llc3652%
Vilex Llc2232%
Cpm Medical Consultants, Llc69%
Biomet Orthopedics, Llc46%
Exactech, Inc.11%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

VARISATION STAPLEØ 1,0MMNitinex Memory StapleDynaBridgeEPIC SMALL STAPLEOrbitum VI StapleOrbitum X Staple

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

FDA product codes

CodeNameDevices
JDRStaple, Fixation, Bone64
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY10
HWCScrew, fixation, bone4
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL3
MNHOrthosis, spondylolisthesis spinal fixation3
MNIORTHOSIS, SPINAL PEDICLE FIXATION3

GMDN & GCC registration

  • GMDN code 61668 · non‑implantable
  • Single‑use 100% · sterile 35% · 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

No structured size data on the register.

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

How many orthopaedic bone staple, non-adjustable, non-sterile products are registered in the US?

69 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic bone staple, non-adjustable, non-sterile", from 5 companies. The largest labeler is Fusion Orthopedics, Llc with 52% of records.

Which FDA product codes apply?

JDR (Staple, Fixation, Bone), KWQ (APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY), HWC (Screw, fixation, bone), KWP (APPLIANCE, FIXATION, SPINAL INTERLAMINAL)

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?

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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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