Consulting Wallah › Device Explorer › Other devices › Orthopaedic osteotome blade, reusable
Device Explorer · FDA GUDID · GMDN 37837

Orthopaedic osteotome blade, reusable

A sharp component of an orthopaedic osteotome intended to be attached to a dedicated handle (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is typically flat or curv

US‑registered devices351in commercial distribution
Companies18labelers on GUDID
Single‑use7%of device records
Sterile8%labelled sterile
Prescription50%Rx‑only share
ShareLinkedIn

Share of device records

Hpf Srl7020%
Biomet Orthopedics, Llc6117%
Ortho Development Corporation5115%
Sontec Instruments, Inc.4513%
Sklar Corporation288%
Rp Medical Inc165%
Osseus Fusion Systems, Llc144%
Arthrex, Inc.113%

Top labelers

CompanyDevicesShare
Hpf Srl7020%
Biomet Orthopedics, Llc6117%
Ortho Development Corporation5115%
Sontec Instruments, Inc.4513%
Sklar Corporation288%
Rp Medical Inc165%
Osseus Fusion Systems, Llc144%
Arthrex, Inc.113%
Zimmer, Inc.103%
Smith & Nephew, Inc.93%
Teleflex Incorporated82%
Microaire Surgical Instruments Llc72%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

INSTRUMENTNAZ1™ Hip SystemIdentity™Aggressive Calcar BladeAlliance®Avenir Complete®Arthrex®Intramedullary Bone SawDiscovery™Choice InstrumentsComprehensive® SRS InstrumentCompress® InstrumentComprehensive® Shoulder SystemAETOS Shoulder SystemCYLINDRICORE INSTRUMENTS

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

FDA product codes

CodeNameDevices
LXHOrthopedic Manual Surgical Instrument76
GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL47
HTSKNIFE, ORTHOPEDIC40
LXHOrthopedic manual surgical instrument39
EMMCHISEL, OSTEOTOME, SURGICAL28
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT24

GMDN & GCC registration

  • GMDN code 37837 · non‑implantable
  • Single‑use 7% · sterile 8% · Rx‑only 50% · 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

Width (Millimeter) · 53Height (Millimeter) · 50Length (Inch) · 45Length (Millimeter) · 28Angle (degree) · 18

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

How many orthopaedic osteotome blade, reusable products are registered in the US?

351 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic osteotome blade, reusable", from 18 companies. The largest labeler is Hpf Srl with 20% of records.

Which FDA product codes apply?

LXH (Orthopedic Manual Surgical Instrument), GFA (BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL), HTS (KNIFE, ORTHOPEDIC), LXH (Orthopedic manual surgical instrument)

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.

How do I get quotes?

Add orthopaedic osteotome blade, reusable to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

Request quotes for Orthopaedic osteotome blade, reusable

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying orthopaedic osteotome blade, reusable for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

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.

Get quotes →