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Device Explorer · FDA GUDID · GMDN 12696

Orthopaedic inorganic implant inserter/extractor, reusable

A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configur

US‑registered devices8,754in commercial distribution
Companies211labelers on GUDID
Single‑use6%of device records
Sterile1%labelled sterile
Prescription81%Rx‑only share
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Share of device records

Innomed, Inc.6628%
Biomet Orthopedics, Llc5737%
Seaspine Orthopedics Corporation4525%
Alphatec Spine, Inc.4245%
Medtronic Sofamor Danek, Inc.3324%
Smith & Nephew, Inc.2883%
Nuvasive, Inc.2553%
Depuy Spine, Llc2042%

Top labelers

CompanyDevicesShare
Innomed, Inc.6628%
Biomet Orthopedics, Llc5737%
Seaspine Orthopedics Corporation4525%
Alphatec Spine, Inc.4245%
Medtronic Sofamor Danek, Inc.3324%
Smith & Nephew, Inc.2883%
Nuvasive, Inc.2553%
Depuy Spine, Llc2042%
Highridge Medical, Llc1812%
Zimmer, Inc.1792%
Vb Spine Llc1592%
Depuy (Ireland)1542%

Company = labeler of record on GUDID. 211 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

T2, PANGEAPANGEAT2REUNIONINSTRUMENTTritanium PLSR90DInstrumentsTritanium TLTritanium CMonterey ALXia 3NAVARIAXTritanium XInstrument

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 INSTRUMENT1,416
LXHOrthopedic Manual Surgical Instrument980
HWBExtractor868
MAXIntervertebral fusion device with bone graft, lumbar812
LXHOrthopedic manual surgical instrument761
HWBEXTRACTOR598

GMDN & GCC registration

  • GMDN code 12696 · non‑implantable
  • Single‑use 6% · sterile 1% · Rx‑only 81% · 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) · 111Height (Millimeter) · 98Length (Inch) · 72Outer Diameter (Millimeter) · 61Length (Millimeter) · 59Lumen/Inner Diameter (Millimeter) · 21

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

How many orthopaedic inorganic implant inserter/extractor, reusable products are registered in the US?

8,754 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic inorganic implant inserter/extractor, reusable", from 211 companies. The largest labeler is Innomed, Inc. with 8% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LXH (Orthopedic Manual Surgical Instrument), HWB (Extractor), MAX (Intervertebral fusion device with bone graft, lumbar)

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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