Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010060157

FEI Number

3010060157

Entity Name

JANCO, INC.

City/State/Country

Rollinsford, NH, US

Establishment Address

50 Goodwin Road, Rollinsford, NH 03869, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Janco, Inc. (Owner Number: 10043068)

Owner / Operator Contact Address

50 Goodwin Road, Rollinsford, NH 03869, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SurePass CTR; TrapEZ Fiber-Connect KinematX Suture Anchor PEEK 3mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm ClariTEE probe Pad, Disposable, Traction Boot Leg Holder Pad: Allen (BoxedNon Sterile) Leg Holder Pad: S&N (BoxedNon Sterile) Tensile Tape Shuttle Wire Suture Passer Force DFX Suture; Force DFX Suture-Xtreme PunchTac Suture Anchors Bedding, Disposable, Medical- HDS Disposable Pad Kit; HDS Postless Hip Disposables Kit Interference Screw Insertion Tool GFU-100 NITINEX Surgical Kit; NITINEX Staple Sizer Assembly

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2025-12-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-06-12
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-05-11
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2020-07-21
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-07-21
JWJ	Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained	Orthopedic	Class 2	888.3800	2020-12-22
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-15
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-12-05
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2016-12-13
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2016-12-13
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-06-13
HWQ	Passer	Orthopedic	Class 1	888.4540	2023-11-30
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2024-02-15
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-15
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2016-12-13
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-12-13
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2023-12-13
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2020-07-21
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2013-01-23
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2023-08-21

Official Correspondent

Barbara Grimes

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Janco, Inc.

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
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08
K082949	OrthoPediatrics Corp.	ORTHOPEDIATRICS BONE SCREWS	2008-11-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010060157. Last updated year: 2026. Please use registration number 3010060157 when referencing this establishment in official correspondence.