Consulting Wallah › Device Explorer › Other devices › Laminectomy retractor, self-retaining
Device Explorer · FDA GUDID · GMDN 13384

Laminectomy retractor, self-retaining

A self-locking, surgical instrument, used for separating the edges or drawing aside the margins of a surgical incision to permit excision of the lamina of the vertebral posterior arch; this can be necessary to expose a portion of the spinal cord for removal of

US‑registered devices141in commercial distribution
Companies3labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Ambler Surgical Corp.13495%
Boss Instruments, Ltd., Inc.64%
Seaspine Orthopedics Corporation11%

Top labelers

CompanyDevicesShare
Ambler Surgical Corp.13495%
Boss Instruments, Ltd., Inc.64%
Seaspine Orthopedics Corporation11%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Stealth SurgicalBoss InstrumentsAmbler SurgicalSeaSpine Spacer System - Pacifica

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

FDA product codes

CodeNameDevices
GZTRETRACTOR, SELF-RETAINING, FOR NEUROSURGERY139
HAERONGEUR, MANUAL1
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT1

GMDN & GCC registration

  • GMDN code 13384 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 100% · 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

No structured size data on the register.

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

How many laminectomy retractor, self-retaining products are registered in the US?

141 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Laminectomy retractor, self-retaining", from 3 companies. The largest labeler is Ambler Surgical Corp. with 95% of records.

Which FDA product codes apply?

GZT (RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY), HAE (RONGEUR, MANUAL), 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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