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Device Explorer · FDA GUDID · GMDN 47967

Orthopaedic bone void filling material, synthetic/animal-derived

A bioabsorbable, implantable device made of synthetic materials (e.g., ceramics such as tricalcium phosphate or hydroxyapatite) combined with animal-derived bone growth factors (e.g., bovine collagen) intended to replace bone lost through trauma, surgery, or p

US‑registered devices308in commercial distribution
Companies12labelers on GUDID
Single‑use100%of device records
Sterile99%labelled sterile
Prescription99%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Berkeley Advanced Biomaterials, Llc10133%
Stryker Corporation3411%
Seaspine Orthopedics Corporation3411%
Curasan Ag299%
Novabone Products, Llc289%
Isotis Orthobiologics, Inc.268%
Dsm Biomedical, Inc.258%
Xtant Medical Holdings, Inc.155%

Top labelers

CompanyDevicesShare
Berkeley Advanced Biomaterials, Llc10133%
Stryker Corporation3411%
Seaspine Orthopedics Corporation3411%
Curasan Ag299%
Novabone Products, Llc289%
Isotis Orthobiologics, Inc.268%
Dsm Biomedical, Inc.258%
Xtant Medical Holdings, Inc.155%
Nuvasive, Inc.72%
Orthofix Us Llc52%
Revisios B.V.31%
Kuros Biosciences B.V.10%

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

Brand names on the register (sample)

Vitoss BiModalTriForm Moldable FoamTriForm Flexible Foam StripCERASORB® Ortho FoamCERACELL Ortho FoamVerteFrameMatriform SI-StripMatriform StripMatriform Extra LargeMatriform LargeMatriform MediumMatriform SmalFormaGraftSTRATOFUSE StripEvoGraftnanOss 3D Plus Advanced Bone Graft Substitute

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

FDA product codes

CodeNameDevices
MQVFiller, Bone Void, Calcium Compound233
MQVFILLER, BONE VOID, CALCIUM COMPOUND135
OISCalcium Salt Bone Void Filler, Drillable, Non-Screw Augmenta10
LYCBone grafting material, synthetic4

GMDN & GCC registration

  • GMDN code 47967 · implantable
  • Single‑use 100% · sterile 99% · Rx‑only 99% · 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

Total Volume (Milliliter) · 26Length (Millimeter) · 13Width (Millimeter) · 13Height (Millimeter) · 13Circumference (Millimeter) · 6Total Volume (Centiliter) · 1

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

How many orthopaedic bone void filling material, synthetic/animal-derived products are registered in the US?

308 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic bone void filling material, synthetic/animal-derived", from 12 companies. The largest labeler is Berkeley Advanced Biomaterials, Llc with 33% of records.

Which FDA product codes apply?

MQV (Filler, Bone Void, Calcium Compound), MQV (FILLER, BONE VOID, CALCIUM COMPOUND), OIS (Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmenta), LYC (Bone grafting material, synthetic)

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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