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Device Explorer · FDA GUDID · GMDN 33997

Surgical drill guide obturator

A surgical device designed to fill the lumen of a drill guide during its insertion to a surgical site primarily to prevent tissue obstruction of the drill guide lumen. When the drill guide is firmly placed at the chosen position on the bone surface, the obtura

US‑registered devices298in commercial distribution
Companies32labelers on GUDID
Single‑use4%of device records
Sterile1%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Smith & Nephew, Inc.12843%
Biomet Orthopedics, Llc217%
Medos International Sàrl186%
Synthes Gmbh145%
Arthrex, Inc.103%
Conmed Corporation93%
Depuy Spine, Llc93%
Stryker Corporation83%

Top labelers

CompanyDevicesShare
Smith & Nephew, Inc.12843%
Biomet Orthopedics, Llc217%
Medos International Sàrl186%
Synthes Gmbh145%
Arthrex, Inc.103%
Conmed Corporation93%
Depuy Spine, Llc93%
Stryker Corporation83%
Wright Medical Technology, Inc.83%
Cayenne Medical, Inc.83%
Aap Implantate Ag72%
Parcus Medical Llc72%

Company = labeler of record on GUDID. 32 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CinchLock FlexICONIXApexOsteotec CBG Soft Tissue Displacer LargeOsteotec CBG Soft Tissue Displacer SmallTwinLoop FLEXTwinLoopNABIORAPTORSMALL CANNULATED SCREWSCLEAR-TRACTRIGENARTHROGARDETRUCLEARTM ObturatorN/AREDUX

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

FDA product codes

CodeNameDevices
NBHACCESSORIES,ARTHROSCOPIC183
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT64
LXHOrthopedic manual surgical instrument18
LXHOrthopedic Manual Surgical Instrument17
FZXGuide, surgical, instrument16
MBIFastener, fixation, nondegradable, soft tissue13

GMDN & GCC registration

  • GMDN code 33997 · non‑implantable
  • Single‑use 4% · sterile 1% · Rx‑only 96% · 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 (Centimeter) · 3Guidewire Diameter (Millimeter) · 1Guidewire Length (Millimeter) · 1

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

How many surgical drill guide obturator products are registered in the US?

298 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical drill guide obturator", from 32 companies. The largest labeler is Smith & Nephew, Inc. with 43% of records.

Which FDA product codes apply?

NBH (ACCESSORIES,ARTHROSCOPIC), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LXH (Orthopedic manual surgical instrument), 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.

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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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