Consulting Wallah › Device Explorer › Orthopaedic implants › Bone-screw internal spinal fixation system, steril
Device Explorer · FDA GUDID · GMDN 61324

Bone-screw internal spinal fixation system, sterile

An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (D

US‑registered devices5,135in commercial distribution
Companies19labelers on GUDID
Single‑use92%of device records
Sterile95%labelled sterile
Prescription84%Rx‑only share
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Share of device records

Biomet Spine Llc1,88037%
Aegis Spine, Inc.70414%
Back 2 Basic Direct, Llc4018%
Spineway3767%
Ldr Spine Usa, Inc.3587%
Spineart Sa3497%
Innovative Surgical Designs2785%
Sintx Technologies, Inc.1773%

Top labelers

CompanyDevicesShare
Biomet Spine Llc1,88037%
Aegis Spine, Inc.70414%
Back 2 Basic Direct, Llc4018%
Spineway3767%
Ldr Spine Usa, Inc.3587%
Spineart Sa3497%
Innovative Surgical Designs2785%
Sintx Technologies, Inc.1773%
Lanterna Medical Technologies Gmbh1242%
Medicrea International1062%
Spinal Balance, Inc.902%
Intelligent Implant Systems, Llc892%

Company = labeler of record on GUDID. 19 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Mont Blanc MIS Spinal SystemsMont Blanc Spinal SystemsMont Blanc Evo SystemsC-PlateSpineTune TLEasyspinePASS LPDynesys®Dynesys® Top-Loading SystemPOLARIS 5.5 SPINAL SYSTEMSOLITAIRE-C CERVICAL SPACER SYSLINEUM OCT SPINE SYSTEMLineum® OCTMaxAn® Anterior CervicalC-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEMMAXAN ANTERIOR CERVICAL PLATE SYSTEM

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

FDA product codes

CodeNameDevices
MNHOrthosis, spondylolisthesis spinal fixation1,777
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL1,532
KWPAppliance, Fixation, Spinal Interlaminal1,416
MNIOrthosis, Spinal Pedicle Fixation1,408
NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Dis1,341
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1,326

GMDN & GCC registration

  • GMDN code 61324 · non‑implantable
  • Single‑use 92% · sterile 95% · Rx‑only 84% · OTC 2%
  • 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) · 2,197Outer Diameter (Millimeter) · 1,531Height (Millimeter) · 184Width (Millimeter) · 111Angle (degree) · 6Length (Micrometer) · 3

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

How many bone-screw internal spinal fixation system, sterile products are registered in the US?

5,135 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bone-screw internal spinal fixation system, sterile", from 19 companies. The largest labeler is Biomet Spine Llc with 37% of records.

Which FDA product codes apply?

MNH (Orthosis, spondylolisthesis spinal fixation), KWP (APPLIANCE, FIXATION, SPINAL INTERLAMINAL), KWP (Appliance, Fixation, Spinal Interlaminal), MNI (Orthosis, Spinal Pedicle Fixation)

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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