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Device Explorer · FDA GUDID · GMDN 61884

Cadaveric-donor/synthetic mineral bone graft

A sterile implantable device consisting of demineralized bone matrix (DBM) processed from cadaveric human bone (allograft) and mixed with bioabsorbable synthetic minerals (e.g., calcium phosphate), intended to fill bony voids or gaps in the skeletal system (e.

US‑registered devices59in commercial distribution
Companies3labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Berkeley Advanced Biomaterials, Llc4576%
Amend Surgical, Inc.1119%
Vivorte, Inc35%

Top labelers

CompanyDevicesShare
Berkeley Advanced Biomaterials, Llc4576%
Amend Surgical, Inc.1119%
Vivorte, Inc35%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Apex BG+ 10cc PuttyApex BG+ 5cc PuttyApex BG+ 2cc PuttyBio V BP Bioactive Glass with DBM PuttyBio V BP Bioactive Glass with DBM Putty - 5.0 ccBio V BP Bioactive Glass with DBM Putty - 2.0 ccNanoFuse Bioactive Matrix - 1.0 ccNanoFuse Bioactive Matrix - 10.0 ccNanoFuse Bioactive Matrix - 5.0 ccNanoFuse Bioactive Matrix - 2.0 ccB-GENIN StripR-GENIN StripR-GENIN PuttyB-GENIN PuttyTrabexus®

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

FDA product codes

CodeNameDevices
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)59
MQVFiller, Bone Void, Calcium Compound59

GMDN & GCC registration

  • GMDN code 61884 · implantable
  • Single‑use 100% · sterile 100% · 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

Total Volume (Milliliter) · 8

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

No closely related category with 50+ devices.

How many cadaveric-donor/synthetic mineral bone graft products are registered in the US?

59 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cadaveric-donor/synthetic mineral bone graft", from 3 companies. The largest labeler is Berkeley Advanced Biomaterials, Llc with 76% of records.

Which FDA product codes apply?

MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)), MQV (Filler, Bone Void, Calcium Compound)

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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