Data / Medical devices / United States / Precision Medical Technologies- North Manchester Manufacturing Facility

Precision Medical Technologies- North Manchester Manufacturing Facility: FDA-registered device maker in N Manchester, IN, United States, 4 510(k) clearances

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

Precision Medical Technologies- North Manchester Manufacturing Facility is registered with the FDA (registration 3015179588) in N Manchester, IN, United States. It lists 34 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 1, 2012. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Precision Medical Technologies- North Manchester Manufacturing Facility

FDA registration number: 3015179588
Address: 400 Beckley Street, N Manchester, IN, United States, 46962
Owner or operator: Precision Medical Technologies (9025575)
Roles: Contract manufacturer, Manufacturer
First device listed: June 17, 2008
Registered through: 2026
Brand names listed: N/A

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Spinal Interlaminal	KWP	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Manufacturer	accessdata.fda.gov
Bender	HXW	1	Contract manufacturer	accessdata.fda.gov
Bit, Drill	HTW	1	Contract manufacturer	accessdata.fda.gov
Broach	HTQ	1	Contract manufacturer	accessdata.fda.gov
Chisel, Surgical, Manual	FZO	1	Contract manufacturer	accessdata.fda.gov
Driver, Prosthesis	HWR	1	Contract manufacturer	accessdata.fda.gov
Elevator	HTE	1	Contract manufacturer	accessdata.fda.gov
Forceps	HTD	1	Contract manufacturer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Contract manufacturer	accessdata.fda.gov
Impactor	HWA	1	Contract manufacturer	accessdata.fda.gov
Instrument, Cutting, Orthopedic	HTZ	1	Contract manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Contract manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Thoracic	PHM	2	Contract manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Cervical	OVE	2	Contract manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Lumbar	OVD	2	Contract manufacturer	accessdata.fda.gov
Mallet	HXL	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
Osteotome, Manual	GFI	1	Contract manufacturer	accessdata.fda.gov
Reamer	HTO	1	Contract manufacturer	accessdata.fda.gov
Retractor	GAD	1	Contract manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Manufacturer	accessdata.fda.gov
Spinal Vertebral Body Replacement Device	MQP	2	Contract manufacturer	accessdata.fda.gov
Spinal Vertebral Body Replacement Device - Cervical	PLR	2	Contract manufacturer	accessdata.fda.gov
Support, Patient Position	CCX	1	Contract manufacturer	accessdata.fda.gov
Table, Operating-Room, Ac-Powered	FQO	1	Contract manufacturer	accessdata.fda.gov
Tamp	HXG	1	Contract manufacturer	accessdata.fda.gov
Tap, Bone	HWX	1	Manufacturer	accessdata.fda.gov
Template	HWT	1	Contract manufacturer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Contract manufacturer	accessdata.fda.gov
Trephine	HWK	1	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
October 1, 2012	K120998	SOLSTICE CROSS CONNECTOR	KWP	Substantially Equivalent	Life Spine	accessdata.fda.gov
October 13, 2010	K093093	SMALL PLATEAU SPACER SYSTEM	ODP	Substantially Equivalent	Life Spine	accessdata.fda.gov
January 19, 2010	K093200	LIFE SPINE LUMBAR PLATE SYSTEM	KWQ	Substantially Equivalent	Life Spine	accessdata.fda.gov
March 13, 2007	K070285	LIFE SPINE ANTERIOR CERVICAL PLATE SYSTEM	KWQ	Substantially Equivalent	Life Spine	accessdata.fda.gov

Compare with other makers

Updated October 1, 2012. 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.