Medicraft Inc

FDA Device Registration & Listing · Elmwood Park, NJ, US · Registration 3009538923

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
3009538923
FEI Number
3009538923
Entity Name
Medicraft Inc
City/State/Country
Elmwood Park, NJ, US
Establishment Address
50 Bushes Ln, Elmwood Park, NJ 07407, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Medicraft Inc/Creighton (Owner Number: 10042540)
Owner / Operator Contact Address
50 Bushes Lane, Elmwood Park, NJ 07407, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Stryker Mako Medtronic

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2012-12-06
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2020-04-08
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2022-11-18
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-06-20

Official Correspondent

Shalyn Creighton

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medicraft Inc/Creighton
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
K243425 Talladium España, SL Guided DAS Surgical Kit 2025-07-22
K213209 K1 Medical, LLC EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device 2021-12-28
K012105 Symmetry Medical, Inc. POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM 2002-08-02
K243317 Infinitum Eta, Ltd. NUVENTUS NV.C™ Surgical Cassette and Tray 2025-02-11

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009538923. Last updated year: 2026. Please use registration number 3009538923 when referencing this establishment in official correspondence.
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