KAPSTONE MANUFACTURING

FDA Device Registration & Listing · Charlotte, NC, US · Registration 3016248538

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
3016248538
FEI Number
3016248538
Entity Name
KAPSTONE MANUFACTURING
City/State/Country
Charlotte, NC, US
Establishment Address
520 Elliot St, Charlotte, NC 28202, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Kapstone Manufacturing (Owner Number: 10062247)
Owner / Operator Contact Address
520 Elliot St, Charlotte, NC 28202, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ExoToe Suture Shield Pathfinder ACL System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2025-05-22
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2026-06-15
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2025-05-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Kapstone Manufacturing
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
K153770 In2bones Sas OS2(R)-VP Varisation Staple 2016-03-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-2023 Synthes (USA) Products LLC 2
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016248538. Last updated year: 2026. Please use registration number 3016248538 when referencing this establishment in official correspondence.
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