Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009631939

FEI Number

3009631939

Entity Name

RED STAR CONTRACT MANUFACTURING INC.

City/State/Country

Larwill, IN, US

Establishment Address

1560 N State Road 5, Larwill, IN 46764, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Red Star Contract Manufacturing (Owner Number: 10046073)

Owner / Operator Contact Address

1560 N State Road 5, Larwill, IN 46764, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

WishFIX Sterile Spine Pedicle Screw System WishBone Plate and Screw WishFIX Injection molded housing assembly Drill Bit WishBone Plate and Screw WishFIX WishBone Plate and Screw WishBone K-Wire System WishFIX WishFIX WishBone Plate and Screw WishBone Broken Screw Removal System WishBone Plate and Screw Sterile Spine Pedicle Screw System Sterile Spine Pedicle Screw System WishBone Plate and Screw Wishbone Medical K-Wire System AlloMate Arthroscopic OCD Instrument System WishFIX WishBone K-Wire System AlloMate Instrument System Smooth / Threaded / Fluted Pin Bone Biopsy Cannula/Instrument WishBone Plate and Screw WishFIX Nitinol Wire Loop PRIMA Femoral Locking Plate System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWT	Template	Orthopedic	Class 1	888.4800	2022-09-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2022-09-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-09-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2022-09-28
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2022-09-28
OBT	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis	Orthopedic	Class 2	888.3030	2021-05-14
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2021-05-14
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2021-05-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-09-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-09-28
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2022-09-28
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2022-09-28
HWB	Extractor	Orthopedic	Class 1	888.4540	2021-05-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-05-14
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-05-14
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-09-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2022-09-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-09-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2022-09-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2022-09-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-09-28
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-09-28
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2021-05-14
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2021-05-14
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-09-28
JYQ	Loop, Wire	Ear, Nose, Throat	Class 1	874.4420	2025-12-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-07-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-07-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Red Star Contract Manufacturing

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013680140	WISHBONE MEDICAL INC.	Larwill, IN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K012175	Encore Orthopedics, Inc.	PASS SPINAL SYSTEM	2001-07-31
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05
K252461	Spinal Resources, Inc.	Swedge Pedicle Screw Fixation System Bezier Rod	2026-01-13
K140696	Pioneer Surgical Technology, Inc.	STREAMLINE TL SPINAL FIXATION SYSTEM	2014-04-10
K141398	Medicrea International SA	PASS LP SPINAL SYSTEM	2015-01-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009631939. Last updated year: 2026. Please use registration number 3009631939 when referencing this establishment in official correspondence.