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Device Explorer · FDA GUDID · GMDN 45612

Soft-tissue/mesh anchor, non-bioabsorbable

A non-bioabsorbable device designed to be implanted into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials/implants (e.g., mesh, sutures); it is not intended to anchor soft tissues to bone, nor repair cartilage, an

US‑registered devices215in commercial distribution
Companies19labelers on GUDID
Single‑use89%of device records
Sterile86%labelled sterile
Prescription63%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Medacta International Sa8640%
Hnm Stainless, Llc.2311%
Medtronic, Inc.2210%
T.A.G Medical Products Agricultural Cooperative Association209%
Biomet Orthopedics, Llc94%
Medtronic Vascular, Inc.94%
In2Bones Usa, Llc63%
Nalu Medical, Inc.63%

Top labelers

CompanyDevicesShare
Medacta International Sa8640%
Hnm Stainless, Llc.2311%
Medtronic, Inc.2210%
T.A.G Medical Products Agricultural Cooperative Association209%
Biomet Orthopedics, Llc94%
Medtronic Vascular, Inc.94%
In2Bones Usa, Llc63%
Nalu Medical, Inc.63%
Medtronic Sofamor Danek, Inc.63%
Biopro, Inc.63%
Davol Inc.42%
Via Surgical Ltd31%

Company = labeler of record on GUDID. 19 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TissueTak™FasTouch™SaffronNABIOTRONIKJuggerStitch®JUGGERSTITCH™MAXFIRE MARXMENMAXFIREHerculesHNM MEDICALNevro®Nalu Medical, Inc.BightForceCAPSUREPERMAFIX

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

FDA product codes

CodeNameDevices
MBIFastener, Fixation, Nondegradable, Soft Tissue117
OTDEndovascular suturing system36
MBIFastener, fixation, nondegradable, soft tissue29
GDWSTAPLE, IMPLANTABLE10
JDRStaple, Fixation, Bone10
HWCScrew, Fixation, Bone10

GMDN & GCC registration

  • GMDN code 45612 · implantable
  • Single‑use 89% · sterile 86% · Rx‑only 63% · 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

Outer Diameter (Millimeter) · 38Length (Centimeter) · 33Length (Millimeter) · 20

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

How many soft-tissue/mesh anchor, non-bioabsorbable products are registered in the US?

215 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Soft-tissue/mesh anchor, non-bioabsorbable", from 19 companies. The largest labeler is Medacta International Sa with 40% of records.

Which FDA product codes apply?

MBI (Fastener, Fixation, Nondegradable, Soft Tissue), OTD (Endovascular suturing system), MBI (Fastener, fixation, nondegradable, soft tissue), GDW (STAPLE, IMPLANTABLE)

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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