Consulting Wallah › Device Explorer › Other devices › Bone lever/elevator, reusable
Device Explorer · FDA GUDID · GMDN 35048

Bone lever/elevator, reusable

A manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of size

US‑registered devices6,139in commercial distribution
Companies151labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription64%Rx‑only share
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Share of device records

Alphatec Spine, Inc.88714%
Avalign Technologies, Inc.4137%
Life Instrument Corporation4027%
Surgical Direct, Inc.2544%
Highridge Medical, Llc2344%
Aspen Surgical Products, Inc.2224%
Nordent Manufacturing Inc2224%
Novo Surgical, Inc.1743%

Top labelers

CompanyDevicesShare
Alphatec Spine, Inc.88714%
Avalign Technologies, Inc.4137%
Life Instrument Corporation4027%
Surgical Direct, Inc.2544%
Highridge Medical, Llc2344%
Aspen Surgical Products, Inc.2224%
Nordent Manufacturing Inc2224%
Novo Surgical, Inc.1743%
Medtronic Sofamor Danek, Inc.1633%
Degen Medical, Inc.1502%
Rz-Medizintechnik Gmbh1432%
Elmed Incorporated1152%

Company = labeler of record on GUDID. 151 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAPANGEAEDINTRAKENDOTRACINSTRUMENTRELIANCE LITeVARIAXREUNIONSTILLE ElevatorsBone Lever, LargeBone Lever, SmallPeriosteal Elevator, StraightPeriosteal Elevator, Round EdgeBone ElevatorBucking BarSPAIRE Trethowan Bone Lever, 220mm Length, Ring

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

FDA product codes

CodeNameDevices
HTEELEVATOR1,479
GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY1,185
HTEElevator772
GEGElevator, Surgical, General & Plastic Surgery633
EMJElevator, Surgical, Dental337
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT275

GMDN & GCC registration

  • GMDN code 35048 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 64% · 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

Length (Inch) · 418Width (Millimeter) · 230Height (Millimeter) · 110Length (Centimeter) · 107Width (Inch) · 74Depth (Millimeter) · 46

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

How many bone lever/elevator, reusable products are registered in the US?

6,139 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bone lever/elevator, reusable", from 151 companies. The largest labeler is Alphatec Spine, Inc. with 14% of records.

Which FDA product codes apply?

HTE (ELEVATOR), GEG (ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY), HTE (Elevator), GEG (Elevator, Surgical, General & Plastic Surgery)

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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