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Device Explorer · FDA GUDID · GMDN 61531

Lumbar decompression interspinous spacer

A device intended to be implanted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures, typically to treat a patient with symptomatic degenerative lumbar spinal stenosis (DLSS). It is typically des

US‑registered devices72in commercial distribution
Companies9labelers on GUDID
Single‑use90%of device records
Sterile61%labelled sterile
Prescription93%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Medtronic Sofamor Danek, Inc.2129%
Nuvasive, Inc.1521%
Flospine Llc811%
Ldr Spine Usa, Inc.710%
Paradigm Spine Gmbh57%
Companion Spine France57%
Boston Scientific Neuromodulation Corporation57%
Surgentec, Llc57%

Top labelers

CompanyDevicesShare
Medtronic Sofamor Danek, Inc.2129%
Nuvasive, Inc.1521%
Flospine Llc811%
Ldr Spine Usa, Inc.710%
Paradigm Spine Gmbh57%
Companion Spine France57%
Boston Scientific Neuromodulation Corporation57%
Surgentec, Llc57%
Empirical Spine, Inc.11%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

coflex-F™ System 16mmcoflex-F™ System 14mmcoflex-F™ System 12mmcoflex-F™ System 10mmcoflex-F™ system, 8mmDIAM™ Spinal Stabilization SystemInterBRIDGEAffixSuperion™Limiflex Dynamic Sagittal TetherX-STOP® Interspinous SpacerSpinous Process Plate, 16mmSpinous Process Plate, 14mmSpinous Process Plate, 12mmSpinous Process Plate, 10mmSpinous Process Plate, 8mm

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

FDA product codes

CodeNameDevices
NQOProsthesis, spinous process spacer/plate23
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL19
PEKSpinous process plate17
NQOProsthesis, Spinous Process Spacer/Plate15
PEKSpinous Process Plate15
KWPAppliance, Fixation, Spinal Interlaminal10

GMDN & GCC registration

  • GMDN code 61531 · implantable
  • Single‑use 90% · sterile 61% · Rx‑only 93% · 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

Height (Millimeter) · 18Length (Millimeter) · 10Width (Millimeter) · 10

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

How many lumbar decompression interspinous spacer products are registered in the US?

72 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Lumbar decompression interspinous spacer", from 9 companies. The largest labeler is Medtronic Sofamor Danek, Inc. with 29% of records.

Which FDA product codes apply?

NQO (Prosthesis, spinous process spacer/plate), KWP (APPLIANCE, FIXATION, SPINAL INTERLAMINAL), PEK (Spinous process plate), NQO (Prosthesis, Spinous Process Spacer/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.

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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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