Data / Medical devices / United States / Red Star Contract Manufacturing Inc.

Red Star Contract Manufacturing Inc.: FDA-registered device maker in Larwill, IN, United States, 5 510(k) clearances

Name: Red Star Contract Manufacturing Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Red Star Contract Manufacturing Inc. is registered with the FDA (registration 3009631939) in Larwill, IN, United States. It lists 17 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 12, 2020. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3009631939
Address: 1560 N State Road 5, Larwill, IN, United States, 46764
Owner or operator: Red Star Contract Manufacturing (10046073)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: May 14, 2021
Registered through: 2026
Brand names listed: AlloMate Arthroscopic OCD Instrument System, AlloMate Instrument System, Bone Biopsy Cannula/Instrument, Cannulated Screws, Drill Bit, Injection molded housing assembly, Medline UNITE® REFLEX® MAX NITINOL STAPLE KIT, Nitinol Wire Loop and more

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Spinal Interlaminal	KWP	2	Repackager or relabeler	accessdata.fda.gov
Bit, Drill	HTW	1	Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer	accessdata.fda.gov
Extractor	HWB	1	Contract manufacturer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Lamp, Surgical	FTD	2	Contract manufacturer	accessdata.fda.gov
Loop, Wire	JYQ	1	Contract manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Repackager or relabeler	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Repackager or relabeler	accessdata.fda.gov
Pin, Fixation, Smooth	HTY	2	Contract manufacturer	accessdata.fda.gov
Plate, Bone, Growth Control, Pediatric, Epiphysiodesis	OBT	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Contract manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Contract manufacturer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Template	HWT	1	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Repackager or relabeler	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
May 12, 2020	K192930	Dymaxeon Spine System	NKB	Substantially Equivalent	Back 2 Basics Direct, LLC	accessdata.fda.gov
June 25, 2019	K182704	WishBone Guided Growth System	OBT	Substantially Equivalent	Wishbone Medical	accessdata.fda.gov
May 22, 2017	K170989	Dymaxeon Spine System	NKB	Substantially Equivalent	Back 2 Basics Direct, LLC	accessdata.fda.gov
June 15, 2015	K150184	Dymaxeon Spine System	NKB	Substantially Equivalent	Back 2 Basics Direct, LLC	accessdata.fda.gov
November 5, 2012	K121786	DYMAXEON SPINE SYSTEM	NKB	Substantially Equivalent	B2b Spine Pty, Ltd.	accessdata.fda.gov

Compare with other makers

Updated May 12, 2020. 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.