Consulting Wallah › Device Explorer › Orthopaedic implants › Orthopaedic fixation plate, bioabsorbable
Device Explorer · FDA GUDID · GMDN 45038

Orthopaedic fixation plate, bioabsorbable

A non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy; it is made of a material

US‑registered devices92in commercial distribution
Companies6labelers on GUDID
Single‑use100%of device records
Sterile91%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Inion Oy6166%
Biomet Orthopedics, Llc1415%
Fusion Orthopedics, Llc55%
Synthes Gmbh55%
Biomet Sports Medicine, Llc44%
Surgentec, Llc33%

Top labelers

CompanyDevicesShare
Inion Oy6166%
Biomet Orthopedics, Llc1415%
Fusion Orthopedics, Llc55%
Synthes Gmbh55%
Biomet Sports Medicine, Llc44%
Surgentec, Llc33%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

2.0 mm Inion OTPS™2.5 mm Inion OTPS™Inion OTPS FreedomPlate™Inion OTPS™1.5 mm Inion CPS® Baby2.5 mm Inion CPS®2.0 mm Inion CPS®1.5 mm Inion CPS®REUNITE PLATING SYSTEMCENTRALOC TIBIAL FIXATIONNO PROFILEVERSATILE SCREW SYSTEML15 RC BUTTRESSPolyLock MidfootPolyLock Small BonePolyLock SmallBone

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

FDA product codes

CodeNameDevices
JEYPLATE, BONE121
HRSPlate, fixation, bone52
HWCScrew, fixation, bone19
HRSPLATE, FIXATION, BONE17
MAIFASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE16
HRSPlate, Fixation, Bone4

GMDN & GCC registration

  • GMDN code 45038 · implantable
  • Single‑use 100% · sterile 91% · 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 fixation plate, bioabsorbable products are registered in the US?

92 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic fixation plate, bioabsorbable", from 6 companies. The largest labeler is Inion Oy with 66% of records.

Which FDA product codes apply?

JEY (PLATE, BONE), HRS (Plate, fixation, bone), HWC (Screw, fixation, bone), HRS (PLATE, FIXATION, BONE)

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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