Data / Medical devices / United States / Precision Medical Technologies

Precision Medical Technologies: FDA-registered device maker in Rome City, IN, United States, 1 510(k) clearance

Name: Precision Medical Technologies FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Precision Medical Technologies is registered with the FDA (registration 3014273424) in Rome City, IN, United States. It lists 19 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 20, 2013. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014273424
Address: 103 Warrener Drive --, Rome City, IN, United States, 46784
Owner or operator: Precision Medical Technologies (9025575)
Roles: Contract manufacturer, Specification developer
First device listed: June 17, 2008
Registered through: 2026
Brand names listed: ACL system, OIC Variable Angle Small Fragment Locking Plate System

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	KTT	2	Contract manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Interlaminal	KWP	2	Contract manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Contract manufacturer	accessdata.fda.gov
Curette	HTF	1	Contract manufacturer	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Specification developer	accessdata.fda.gov
Gauge, Depth	HTJ	1	Contract manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Contract manufacturer	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Contract manufacturer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Contract manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Contract manufacturer	accessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	OSH	2	Contract manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Contract manufacturer	accessdata.fda.gov
Rasp	HTR	1	Contract manufacturer	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Contract manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Contract manufacturer	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Contract manufacturer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Contract manufacturer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Contract manufacturer	accessdata.fda.gov
Wrench	HXC	1	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 20, 2013	K130217	ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM	MBI	Substantially Equivalent	OrthoPediatrics Corp.	accessdata.fda.gov

Compare with other makers

Updated June 20, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.