Consulting Wallah › Device Explorer › Other devices › Polymeric osteotomy fusion cage, non-customized
Device Explorer · FDA GUDID · GMDN 61330

Polymeric osteotomy fusion cage, non-customized

A non-customized device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia) following osteotomy to help facilitate bone fusion and alignment; it is typically used with a plating fixation system and may be used in association w

US‑registered devices244in commercial distribution
Companies4labelers on GUDID
Single‑use60%of device records
Sterile12%labelled sterile
Prescription94%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Life Spine, Inc.9238%
Tyber Medical, Llc7230%
Nvision Biomedical Technologies, Inc.6527%
Hnm Total Recon Llc156%

Top labelers

CompanyDevicesShare
Life Spine, Inc.9238%
Tyber Medical, Llc7230%
Nvision Biomedical Technologies, Inc.6527%
Hnm Total Recon Llc156%

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

Brand names on the register (sample)

ORION WEDGEFoot Osteotomy Wedge SystemTrigonTarsa Link BunionTarsa-Link Wedge Fixation SystemP-tanium WedgeOrion Ti PEEK Wedge System InstrumentsWedge System InstrumentsTyber Medical

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

FDA product codes

CodeNameDevices
PLFBone Wedge96
HRSPlate, fixation, bone80
HRSPlate, Fixation, Bone71
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT55
HWCScrew, Fixation, Bone47
HWCScrew, fixation, bone16

GMDN & GCC registration

  • GMDN code 61330 · implantable
  • Single‑use 60% · sterile 12% · Rx‑only 94% · 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

Width (Millimeter) · 32Depth (Millimeter) · 22Height (Millimeter) · 22Length (Millimeter) · 18Angle (degree) · 9Outer Diameter (Millimeter) · 6

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

No closely related category with 50+ devices.

How many polymeric osteotomy fusion cage, non-customized products are registered in the US?

244 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Polymeric osteotomy fusion cage, non-customized", from 4 companies. The largest labeler is Life Spine, Inc. with 38% of records.

Which FDA product codes apply?

PLF (Bone Wedge), HRS (Plate, fixation, bone), 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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