Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2133928

FEI Number

3000717902

Entity Name

Metal Craft Machine & Engineering, Inc.

City/State/Country

Elk River, MN, US

Establishment Address

13760 Business Center Drive, Elk River, MN 55330, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Metal Craft and Riverside Machine & Engineering, Inc. (Owner Number: 9027247)

Owner / Operator Contact Address

13760 Business Drive, --, Elk River, MN 55330, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Triathlon Hinge Knee System VIPER PRIME navigated inserter 2082001500 Rosa Arm Reference Frame 2082000400 Rosa Arm Instrument Interface 2082000200 Rosa Base Reference Frame Closing Tool Quick Connect assembly tool Furlow Insertion Tool Insertion Package 301019010 VIPER PRIME VIPER PRIME 4021-0629-00 RETRACTOR 6" VEIN BAK Ant Lumbar IBF (Zimmer Spine) Triathlon

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2023-02-22
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2013-01-31
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-03-28
HXG	Tamp	Orthopedic	Class 1	888.4540	2013-05-17
HWK	Trephine	Orthopedic	Class 1	888.4540	2013-01-31
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2015-01-12
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2015-01-12
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2015-01-12
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2015-01-12
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2015-01-12
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2015-01-12
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2015-01-12
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2015-01-12
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2012-12-03
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2012-12-03
FSZ	Light, Surgical, Carrier	General, Plastic Surgery	Class 2	878.4580	2012-12-03
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2013-04-06
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-04-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-01
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-12-15
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-31
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-31
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-31
HWA	Impactor	Orthopedic	Class 1	888.4540	2013-01-31
MJO	Prosthesis, Intervertebral Disc	Unknown	Class 3	N/A	2013-01-31
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2013-01-31
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-01-31
GCZ	Retainer, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-04-22
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2013-02-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-02-01
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-02-01
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2013-02-01
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-03-05
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-31
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-31
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-02-06
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-01-31
DTJ	Holder, Heart-Valve, Prosthesis	Cardiovascular	Class 1	870.3935	2013-01-31
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2013-02-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-02-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-02-06
JDB	Prosthesis, Elbow, Semi-Constrained, Cemented	Orthopedic	Class 2	888.3160	2016-03-28
QGA	Penile Implant Surgical Accessories	Gastroenterology, Urology	Class 1	876.3500	2020-04-09
JWJ	Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained	Orthopedic	Class 2	888.3800	2016-03-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-31
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-31
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2013-01-31
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2013-01-31
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2009-01-14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-12-19
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-01-31
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-31
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2013-01-31
HWT	Template	Orthopedic	Class 1	888.4800	2012-12-08
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-01-31
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2013-02-01
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2013-02-01
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2012-12-08
NQP	Posterior Metal/Polymer Spinal System, Fusion	Orthopedic	Class 2	888.3070	2014-12-31
HXC	Wrench	Orthopedic	Class 1	888.4540	2013-01-31
HXB	Probe	Orthopedic	Class 1	888.4540	2013-05-17
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-05-17
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-05-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-05-17
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2013-02-06
GFC	Driver, Surgical, Pin	General, Plastic Surgery	Class 1	878.4820	2013-04-22
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2013-01-31
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-04-06
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-04-06
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-04-06
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-04-06
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-04-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-03-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-02-01
KCH	Hook, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2013-06-07
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2013-02-06
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-12-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-12-19
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-12-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-02-06
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-02-06
KTZ	Caliper	Orthopedic	Class 1	888.4150	2013-12-20
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-31
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2013-01-31
HWJ	Awl	Orthopedic	Class 1	888.4540	2013-01-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-02-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-02-06
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2013-02-01
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-08-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-02-01
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-12-15
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-31
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-31
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2012-12-05
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-12-15
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2012-12-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-03-28
JDB	Prosthesis, Elbow, Semi-Constrained, Cemented	Orthopedic	Class 2	888.3160	2016-03-28
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Orthopedic	Class 2	888.3170	2016-03-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-31
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-31
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-31
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2013-01-31
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2013-01-31
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2015-01-12
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-01-12
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2014-12-31
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2014-12-31
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2014-12-31
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2014-12-31
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2013-01-31
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-02-01
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2013-02-01
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2013-02-01
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-31
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-12-19
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2013-02-01
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2013-02-01
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-03-28
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2021-03-05
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2021-03-05
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2013-04-22

Official Correspondent

Trisha Mowry

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Metal Craft and Riverside Machine & Engineering, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2134285	RIVERSIDE MACHINE & ENGINEERING, INC.	Eau Claire, WI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220628	Waldemar Link GmbH & Co. KG	LINK Endo-Model EVO Knee System	2022-05-03
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11
K002057	Biomet Orthopedics, Inc.	BROOKER TIBIA NAILS	2000-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2133928. Last updated year: 2026. Please use registration number 2133928 when referencing this establishment in official correspondence.