UNITED SURGICAL LLC

FDA Device Registration & Listing · Laotto, IN, US · Registration 2087423

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
2087423
FEI Number
3003707831
Entity Name
UNITED SURGICAL LLC
City/State/Country
Laotto, IN, US
Establishment Address
11654 E 400 S, Laotto, IN 46763, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Repack or Relabel Medical Device
Owner / Operator
UNITED SURGICAL INC dba UNITED ORTHO (Owner Number: 9052541)
Owner / Operator Contact Address
2235 Pennsylvania St, --, Fort Wayne, IN 46803, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Aluminum Crutches FKB ACL Knee Brace Abdominal Binder Walking Boot Sling Arm

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IPR Crutch Physical Medicine Class 1 890.3150 2024-09-23
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2014-02-07
FSD Binder, Abdominal General Hospital Class 1 880.5160 2025-09-05
IQE Orthosis, Lumbar Physical Medicine Class 1 890.3490 2015-03-31
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2014-06-10
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 2015-03-31
IOY Support, Arm Physical Medicine Class 1 890.3475 2015-03-31
IQK Orthosis, Cervical Physical Medicine Class 1 890.3490 2015-03-31

Official Correspondent

Andrew Opliger

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

UNITED SURGICAL INC dba UNITED ORTHO
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-0006-2025 Ossur H F Grjothals 5 Reykjavik Iceland 1
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2087423. Last updated year: 2026. Please use registration number 2087423 when referencing this establishment in official correspondence.
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