FDA Registration
Active
🇺🇸 United States
R.K. Manufacturing
Reg #: 1226146
·
FEI: 3002680121
·
Expires 2026
Products
23
Proprietary Names
35
Establishment Types
1
Classifications
23
Registration Details
- Registration Name
- R.K. Manufacturing
- Registration Number
- 1226146
- FEI Number
- 3002680121
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 34 Executive Drive
- City
- Danbury
- State
- CT
- ZIP
- 06810
- Country
- US
Owner / Operator
- Firm Name
- R.K. MFG. CORP. OF CONNECTICUT
- Operator Number
- 10024924
- Address
- R.K. Manufacturing, 34 Executive Drive
- City
- Danbury
- State
- CT
- Postal Code
- 06810
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2022-10-26 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2025-01-27 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-03-11 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2025-03-11 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2021-06-18 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2023-10-06 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2022-03-28 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2016-09-26 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2016-09-26 |
| Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | OWY | Class 2 | General, Plastic Surgery | No | 2022-10-26 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2020-10-20 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2021-03-16 |
| Pessary, Vaginal | HHW | Class 2 | Obstetrics/Gynecology | No | 2024-06-10 |
| Finger Cot | LZB | Class 1 | General Hospital | No | 2022-02-11 |
| Prosthesis, Toe, Constrained, Polymer | KWH | Class 2 | Orthopedic | No | 2022-10-26 |
| Needle, Suturing, Disposable | GAB | Class 1 | General, Plastic Surgery | No | 2026-04-16 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2014-01-09 |
| Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | NBY | Class 2 | General, Plastic Surgery | No | 2014-03-24 |
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2014-03-24 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2018-02-27 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2025-01-28 |
| Tampon, Menstrual, Unscented | HEB | Class 2 | Obstetrics/Gynecology | No | 2019-01-14 |
| Hydrogel Spacer | OVB | Class 2 | Radiology | No | 2023-02-10 |
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
Nylon Nonabsorbable Surgical Suture
Avitus Pilot Hole Creator 8mm and 11mm
re.t.a
In2Bones RTS Lesser System
AR-8860DS Implant System, PARS Suture
Avitus Bone Harvester
Barrigel
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)