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Device Explorer · FDA GUDID · GMDN 11507

Neurosurgical bone flap elevator

A hand-held, manually-operated surgical instrument used to pry up, lift, and position a bone flap in a neurosurgical procedure upon the skull. Also known as a bone flap elevator it is typically a one-piece instrument that consists of a robust, long, round-nose

US‑registered devices251in commercial distribution
Companies15labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription49%Rx‑only share
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Share of device records

Sklar Corporation10743%
Integra Lifesciences Production Corporation5020%
Avalign Technologies, Inc.239%
Gsource Llc166%
Teleflex Incorporated166%
Peter Lazic Gmbh104%
Adler, Inc.73%
Karl Storz Gmbh & Co. Kg52%

Top labelers

CompanyDevicesShare
Sklar Corporation10743%
Integra Lifesciences Production Corporation5020%
Avalign Technologies, Inc.239%
Gsource Llc166%
Teleflex Incorporated166%
Peter Lazic Gmbh104%
Adler, Inc.73%
Karl Storz Gmbh & Co. Kg52%
Hnm Stainless, Llc.52%
Ambler Surgical Corp.31%
Fehling Instruments Gmbh & Co. Kg21%
Modern Surgical Instruments Llc21%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LAZICNAn.a.HNM MEDICALgSourceAdler Instrument CompanyMSIMSI Precision Specialty InstrumentsMillenniumAvalignPillingAmbler SurgicalPILLINGV. MuellerSklarIntegra® Miltex®

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

FDA product codes

CodeNameDevices
GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY142
HAOINSTRUMENT, SURGICAL, NON-POWERED52
GEGElevator, Surgical, General & Plastic Surgery33
GZXINSTRUMENT, MICROSURGICAL12
HAOInstrument, Surgical, Non-Powered6
LXHOrthopedic manual surgical instrument3

GMDN & GCC registration

  • GMDN code 11507 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 49% · 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) · 7Length (Inch) · 2Length (Centimeter) · 1

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

How many neurosurgical bone flap elevator products are registered in the US?

251 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Neurosurgical bone flap elevator", from 15 companies. The largest labeler is Sklar Corporation with 43% of records.

Which FDA product codes apply?

GEG (ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY), HAO (INSTRUMENT, SURGICAL, NON-POWERED), GEG (Elevator, Surgical, General & Plastic Surgery), GZX (INSTRUMENT, MICROSURGICAL)

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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