Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014273424

FEI Number

3014273424

Entity Name

PRECISION MEDICAL TECHNOLOGIES

City/State/Country

Rome City, IN, US

Establishment Address

103 Warrener Drive, --, Rome City, IN 46784, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Precision Medical Technologies (Owner Number: 9025575)

Owner / Operator Contact Address

2059 N. POUND DR., --, Warsaw, IN 46582, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ACL system

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-12-12
HXC	Wrench	Orthopedic	Class 1	888.4540	2019-03-21
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2018-12-06
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-05-05
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2015-05-05
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2024-06-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-05-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-05-05
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2019-07-08
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-01-29
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-01-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-01-29
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2017-12-21
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-03-26
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2017-12-21
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-12-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2016-12-14
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2016-12-14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2016-12-14
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-12-14
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-12-14
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-12-14
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2024-06-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-01-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-01-29
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2017-12-21

Official Correspondent

Gregory Neher

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Precision Medical Technologies

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015179588	Precision Medical Technologies- North Manchester Manufacturing Facility	N Manchester, IN, US
1835296	PRECISION MEDICAL TECHNOLOGIES	WARSAW, IN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26
K963639	Acromed Corp.	ACROMED PEDICLE SCREW	1996-11-14
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014273424. Last updated year: 2026. Please use registration number 3014273424 when referencing this establishment in official correspondence.