Gyder Surgical Pty Ltd

FDA Device Registration & Listing · Mulgrave Victoria, AU · Registration 3025783933

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3025783933
FEI Number
3025783933
Entity Name
Gyder Surgical Pty Ltd
City/State/Country
Mulgrave Victoria, AU
Establishment Address
30-32 Compark Circuit, Mulgrave Victoria 3170, AU
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Gyder Surgical Us Inc. (Owner Number: 10093254)
Owner / Operator Contact Address
260 Woodbridge Circle, San Mateo, CA 94403, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

GYDER® Hip System OCT AA Impactor

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-04-19
HWA Impactor Orthopedic Class 1 888.4540 2025-09-17

Official Correspondent

No official correspondent registered.

US Agent Details

Sujit Dike Business: Gyder Surgical US Inc Email: sujit@gydersurgical.com Phone: (484) 8867331

Related Public Records

Same Entity

Gyder Surgical Us Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K260601 Blue Belt Technologies, Inc. REAL INTELLIGENCE™ CORI™ 2026-03-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-2024 Blue Belt Technologies, Inc 2
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0010-2008 N/A 1
EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025783933. Last updated year: 2026. Please use registration number 3025783933 when referencing this establishment in official correspondence.
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