Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1226146

FEI Number

3002680121

Entity Name

R.K. Manufacturing

City/State/Country

Danbury, CT, US

Establishment Address

34 Executive Drive, Danbury, CT 06810, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

R.K. MFG. CORP. OF CONNECTICUT (Owner Number: 10024924)

Owner / Operator Contact Address

R.K. Manufacturing, 34 Executive Drive, Danbury, CT 06810, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Artelon FlexBand Plus AR-7212 AC TightRope Repair Kit, Titanium Exceed Biplanar Expandable Interbody System Anchor System Vasculoop BioBrace Reinforced Implant Needle Punch Suture Shuttle, Long Needle Needle Punch Suture Shuttle Instrument, Biopsy-Avitus Bone Harvester with Filter Insert - 5mm, 6mm, and 8mm Avitus DragonWing Large Volume Autograft Delivery Sysem AR-8911DS Mini TightRope Repair Kit (Stainless Steel) AR-8913DS Mini TightRope w/driver Kit Reia Pessary FINGERSHIELDS Arthrex, Inc. Fiberwire, Braided Polyblend #2 Suture, One Blue, One White/Black AR-8926SS Knotless T-Rope Syn-Demosis Repr Kit, SS AR-8926T Knotless T-Rope Syn-Demosis Repr Ti AR-8921CDS Tightrope Syndemosis Repair Cannulated AR-8920CDS Tightrope Syndemosis Repair Cannulated Durasorb Mesh In2Bones RTS 1st System AR-7283, 60 mm Spring Eye Needle (No Suture) In2Bones Syndesmosis Kit StaXx XD System Artelon Suture Anchors StitchKit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2022-10-26
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-01-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-03-11
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2025-03-11
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-06-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-10-06
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-03-28
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-09-26
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2016-09-26
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2022-10-26
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2020-10-20
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2021-03-16
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-01-27
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-08-03
HHW	Pessary, Vaginal	Obstetrics/Gynecology	Class 2	884.3575	2024-06-10
LZB	Finger Cot	General Hospital	Class 1	880.6250	2022-02-11
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2010-10-07
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2020-10-20
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-01-05
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2026-03-23
KWH	Prosthesis, Toe, Constrained, Polymer	Orthopedic	Class 2	888.3720	2022-10-26
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2026-04-16
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-10-26
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2014-01-09
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-10-26
NBY	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	General, Plastic Surgery	Class 2	878.5035	2014-03-24
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2014-03-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2014-03-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

R.K. MFG. CORP. OF CONNECTICUT

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
K220540	Covidien	ProGrip Self-Gripping Polypropylene Mesh	2022-09-22
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1226146. Last updated year: 2026. Please use registration number 1226146 when referencing this establishment in official correspondence.