Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009662572

FEI Number

3009662572

Entity Name

UNIQUE SURGICAL, LLC

City/State/Country

Fort Wayne, IN, US

Establishment Address

6435 W Jefferson Blvd # 242, Fort Wayne, IN 46804, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Repack or Relabel Medical Device

Owner / Operator

Unique Surgical, LLC (Owner Number: 10040874)

Owner / Operator Contact Address

6435 West Jefferson Blvd. #242, Fort Wayne, IN 46804, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Unique Surgical Bayonet Drill Bit Patella Osteotomy Guide Multiple Glenosphere Inserter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2024-06-27
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-03-13
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-05-09

Official Correspondent

Richard Lane

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Unique Surgical, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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3003431869	HILBRO INTERNATIONAL (PVT) LIMITED	SIALKOT Punjab, PK
3023265483	PHEN'X TECHNOLOGIES	Chassieu Auvergne-Rhone-Alpes, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009662572. Last updated year: 2026. Please use registration number 3009662572 when referencing this establishment in official correspondence.