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Device Explorer · FDA GUDID · GMDN 14147

Bone trephine, reusable

An orthopaedic surgical blade designed to cut and remove circular sections of bone, typically for biopsy or percutaneous bone graft harvesting. It is typically a hollow cylinder with a circular, saw-like serrated working edge. It is an exchangeable device that

US‑registered devices713in commercial distribution
Companies60labelers on GUDID
Single‑use13%of device records
Sterile3%labelled sterile
Prescription80%Rx‑only share
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Share of device records

Hager & Meisinger Gesellschaft Mit Beschränkter Haftung7811%
Medtronic Sofamor Danek, Inc.527%
Tecomet Inc.385%
Hoogland Spine Products Gmbh304%
Helmut Zepf Medizintechnik Gmbh304%
Symmetry Medical Inc.274%
Arthrex, Inc.264%
Osstem Implant Co., Ltd.243%

Top labelers

CompanyDevicesShare
Hager & Meisinger Gesellschaft Mit Beschränkter Haftung7811%
Medtronic Sofamor Danek, Inc.527%
Tecomet Inc.385%
Hoogland Spine Products Gmbh304%
Helmut Zepf Medizintechnik Gmbh304%
Symmetry Medical Inc.274%
Arthrex, Inc.264%
Osstem Implant Co., Ltd.243%
Sontec Instruments, Inc.233%
Synthes Gmbh233%
Biotechnology Institute Sl203%
Smith & Nephew, Inc.193%

Company = labeler of record on GUDID. 60 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

FASSIER-DUVAL TELESCOPIC IM SYSTEMTREPHINE DRILLDitron DentalMISTrephine DrillNAOsteotec CBG Tube Saw L - size 8Osteotec CBG Tube Saw L - size 7Osteotec CBG Tube Saw L - size 6Osteotec CBG Tube Saw L - size 5Osteotec CBG Tube Saw S - size 4Osteotec CBG Tube Saw S - size 3Osteotec CBG Tube Saw S - size 2Osteotec CBG Tube Saw S - size 1DENTECHN/A

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

FDA product codes

CodeNameDevices
HWKTREPHINE225
GFFBUR, SURGICAL, GENERAL & PLASTIC SURGERY78
HWKTrephine74
EJLBur, Dental43
HWBExtractor41
DZADrill, Dental, Intraoral39

GMDN & GCC registration

  • GMDN code 14147 · non‑implantable
  • Single‑use 13% · sterile 3% · Rx‑only 80% · 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

Outer Diameter (Millimeter) · 40Length (Inch) · 24Length (Millimeter) · 14Length (Centimeter) · 9Lumen/Inner Diameter (Millimeter) · 5Width (Millimeter) · 4

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

How many bone trephine, reusable products are registered in the US?

713 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bone trephine, reusable", from 60 companies. The largest labeler is Hager & Meisinger Gesellschaft Mit Beschränkter Haftung with 11% of records.

Which FDA product codes apply?

HWK (TREPHINE), GFF (BUR, SURGICAL, GENERAL & PLASTIC SURGERY), HWK (Trephine), EJL (Bur, Dental)

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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