Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1835998

FEI Number

1000518604

Entity Name

INSTRUMENTAL MACHINE & DEVELOPMENT, INC.

City/State/Country

WARSAW, IN, US

Establishment Address

2098 N. POUND DR. W., WARSAW, IN 46582, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

INSTRUMENTAL MACHINE & DEVELOPMENT, INC. (Owner Number: 9023610)

Owner / Operator Contact Address

2098 N. POUND DR. W., --, Warsaw, IN 46582, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

N/A N/A N/A Harmony N/A N/A N/A N/A N/A N/A N/A N/A N/A n/a N/A N/A N/A N/A Harmony N/A N/A N/A N/A none N/A N/A N/A N/A N/A N/A N/A N/A Infix N/A N/A N/A N/A

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTO	Reamer	Orthopedic	Class 1	888.4540	2017-01-31
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2015-10-28
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2016-06-30
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2014-01-03
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2017-05-01
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2012-12-04
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2016-12-27
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2015-10-28
HWI	Corkscrew	Orthopedic	Class 1	888.4540	2016-06-03
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2016-06-03
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2015-10-28
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2017-01-31
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	2014-10-28
IQG	Adaptor, Holder, Syringe	Physical Medicine	Class 1	890.5050	2022-06-22
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2016-06-03
KIK	Hook, Bone	General, Plastic Surgery	Class 1	878.4800	2016-06-21
HWA	Impactor	Orthopedic	Class 1	888.4540	2019-10-28
HWQ	Passer	Orthopedic	Class 1	888.4540	2017-01-31
HXG	Tamp	Orthopedic	Class 1	888.4540	2014-01-03
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2014-10-28
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2016-06-03
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2016-06-21
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2014-10-28
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2016-06-03
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2014-10-28
FKC	Clamp, Cannula	Gastroenterology, Urology	Class 1	876.5540	2017-01-31
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-01-31
HWB	Extractor	Orthopedic	Class 1	888.4540	2015-10-28
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2016-06-03
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2017-01-31
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2016-06-03
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2016-06-03
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2016-06-03
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2014-01-03
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2017-01-31
KQW	Goniometer, Nonpowered	Orthopedic	Class 1	888.1520	2014-10-28
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2016-06-03
KIL	Positioner, Socket	Orthopedic	Class 1	888.4540	2017-01-31

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INSTRUMENTAL MACHINE & DEVELOPMENT, 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
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1835998. Last updated year: 2026. Please use registration number 1835998 when referencing this establishment in official correspondence.