Consulting Wallah › Device Explorer › Orthopaedic implants › Vertebral body prosthesis, non-sterile
Device Explorer · FDA GUDID · GMDN 57806

Vertebral body prosthesis, non-sterile

A non-sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental s

US‑registered devices2,654in commercial distribution
Companies10labelers on GUDID
Single‑use63%of device records
Sterile4%labelled sterile
Prescription69%Rx‑only share
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Share of device records

Seaspine Orthopedics Corporation1,15143%
Medyssey Co., Ltd.68726%
Genesys Orthopedics Systems Llc37014%
Nexxt Spine, Llc1706%
Orthofix Us Llc1706%
Zavation Llc442%
Omnia Medical, Llc402%
Kahtnu Surgical181%

Top labelers

CompanyDevicesShare
Seaspine Orthopedics Corporation1,15143%
Medyssey Co., Ltd.68726%
Genesys Orthopedics Systems Llc37014%
Nexxt Spine, Llc1706%
Orthofix Us Llc1706%
Zavation Llc442%
Omnia Medical, Llc402%
Kahtnu Surgical181%
Ulrich Gmbh & Co. Kg30%
Cardinal Spine Llc10%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

obeliscPRO™ vertebral body replacementShoreline ACSHONOUR™ Spacer SystemPalo Alto ™Omnia Medical VBRZavationCHENA-C PEEK Spacer SystemMISCELLANEOUSPILLARPILLAR PLCONSTRUX PLCONSTRUX TLCONSTRUX - MINI PTCPILLAR SACONSTRUX -PEEK VBRApache

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

FDA product codes

CodeNameDevices
KWPAppliance, Fixation, Spinal Interlaminal687
NKGOrthosis, Cervical Pedicle Screw Spinal Fixation687
MQPSpinal Vertebral Body Replacement Device651
MAXIntervertebral fusion device with bone graft, lumbar582
MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE567
MAXIntervertebral Fusion Device With Bone Graft, Lumbar531

GMDN & GCC registration

  • GMDN code 57806 · non‑implantable
  • Single‑use 63% · sterile 4% · Rx‑only 69% · 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) · 570Width (Millimeter) · 348Height (Millimeter) · 347Angle (degree) · 132Depth (Millimeter) · 101Outer Diameter (Millimeter) · 20

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

How many vertebral body prosthesis, non-sterile products are registered in the US?

2,654 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Vertebral body prosthesis, non-sterile", from 10 companies. The largest labeler is Seaspine Orthopedics Corporation with 43% of records.

Which FDA product codes apply?

KWP (Appliance, Fixation, Spinal Interlaminal), NKG (Orthosis, Cervical Pedicle Screw Spinal Fixation), MQP (Spinal Vertebral Body Replacement Device), MAX (Intervertebral fusion device with bone graft, lumbar)

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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