Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004521401

FEI Number

3004521401

Entity Name

APTIS MEDICAL, LLC.

City/State/Country

Glenview, KY, US

Establishment Address

3602 Glenview Ave, Glenview, KY 40025, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

APTIS MEDICAL, LLC. (Owner Number: 9054354)

Owner / Operator Contact Address

3602 Glenview Ave., --, Glenview, KY 40025, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Orthopedic	Class 2	888.3810	2018-06-27
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2009-05-27
HTO	Reamer	Orthopedic	Class 1	888.4540	2024-08-21
HWT	Template	Orthopedic	Class 1	888.4800	2009-05-27
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2009-05-27
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2009-05-27
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Orthopedic	Class 2	888.3810	2018-06-27
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2009-05-27
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2018-06-29
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2009-05-27
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Orthopedic	Class 2	888.3810	2025-12-09
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Orthopedic	Class 2	888.3810	2007-12-28
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Orthopedic	Class 2	888.3810	2015-05-13
HWA	Impactor	Orthopedic	Class 1	888.4540	2009-05-27

Official Correspondent

Barbara Chesher

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

APTIS MEDICAL, LLC.

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
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
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.

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1226544	MILLSTONE MEDICAL OUTSOURCING LLC.	FALL RIVER, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004521401. Last updated year: 2026. Please use registration number 3004521401 when referencing this establishment in official correspondence.