rms Surgical

FDA Device Registration & Listing · Anoka, MN, US · Registration 3010009693

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010009693
FEI Number
3010009693
Entity Name
rms Surgical
City/State/Country
Anoka, MN, US
Establishment Address
1220 Lund Blvd, Anoka, MN 55303, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
THE CRETEX COMPANIES, INC. (Owner Number: 9001389)
Owner / Operator Contact Address
311 LOWELL AVE., --, Elk River, MN 55330, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

V2F ELEVATOR NavitrackER Pliers Zimmer Persona Personalized Knee System Avenir Complete(TM) Hip System ALPS Proximal Humerus Plating System CLAMP 1.6 MM K-WIRE SLEEVE 1.6MM FAST GUIDE ADAPTOR 2mm Measure Drill Sleeve Large BB-TAK, Threaded Endoskeleton TAS Interbody System Endoskeleton TL Interbody System intervertebral fusion device with bone graft, lumbar Zimmer Persona Personalized Knee System Z1 Hip System FEMORAL DRIVER/IMPACTOR Harmony Retractor System Harmony (Surgical Port) V2F GTS Trunnion Connection Lid ROSA® Pin Caddy VPC SYSTEM - TRAY BASE NEXEL TOTAL ELBOW INSTRUMENT CASES ROSA® TKA Cut Guide Bracket ROSA® Modular Tray ROSA® Knee General Instrument Case Condyles Digitizer Bracket CASE LID ASSY FULL LENGTH LID ASSY HALF LENGTH CASE ASSEMBLY HALF LENGTH H100 ROSA® NexGen® Knee ID Plate VPC SYSTEM - SCREW CADDY ROSA® Persona® Knee ID Plate CASE ASSEMBLY FULL LENGTH H100 ROSA® PKA Validation Tool Bracket ROSA® Modular Instrument Case ROSA® PPK MED CG AL&BR Bracket ROSA® PPK MED CG AR&BL Bracket Universal Tool Assembly Bracket ROSA® Persona Partial Knee ID Plate ROSA® Vanguard® Knee ID Plate CURETTE PERSONA REVISION KNEE SYSTEM GENERAL Mini MaxTorque Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer A.L.P.S. Clavicle Plating System Persona Revision Knee System Persona Revision Zimmer Persona Personalized Knee System Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis OSTEOTOME Walter Scope Holder WalterLorenz Surgical Assist Arm Scope Holder Proximal Humerus Plating System Single/multiple component metallic bone fixation appliances and accessories A.L.P.S. Clavicle Plating System Endoskeleton TCS Interbody System Posterior Cervical Screw System TAP, BONE Pathfinder NXT (Pedical Screw System) V2F Harmony Posterior Optio-C (Anterior Cervical System) Unicompartmental Knee System Spacer Block 5 Degrees 14 Mm Thickness POST WALL IMPACTOR LEFT 24MM OXF MP 10DEG FMRL DRL GD MED OXF MP 10DEG FMRL DRL GD XL OSTEOTOME IMPACTOR LEFT 21MM OSTEOTOME IMPACTOR RIGHT 24MM 90 DEG OSTEOTOME 10X10MM CURVED OSTOTOME 12MM OXF MP 10DEG FMRL DRL GD XS STRAIGHT OSTOTOME 12MM IMPACTOR OSTEO ASM 24MM R OXF MP 10DEG FMRL DRILL GUIDE HEADLESS PIN PULLER STRAIGHT CURETTE 5MM IMPACTOR OSTEO ASM 21MM L CURVED OSTEOTOME 6MM CUP CURETTE RIGHT 5MM CUP CURETTE LEFT 5MM RASP STRAIGHT MIS FLEX SPACER ADAPTER 3.4MM OXF MP 10DEG FMRL DRL GD LG TELESCOPING LOCKING BOOM IMPACTOR OSTEO ASM 24MM L

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-01-29
HTE Elevator General, Plastic Surgery Class 1 878.4800 2021-05-11
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-06-01
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-07-17
HWA Impactor Orthopedic Class 1 888.4540 2013-01-28
EIG Retractor, All Types Dental Class 1 872.4565 2018-07-17
HWD Starter, Bone Screw Orthopedic Class 1 888.4540 2015-05-20
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2016-12-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2019-04-23
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2019-04-23
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2019-04-23
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2019-04-23
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2019-04-23
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2018-03-01
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-03-01
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2020-03-27
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2013-01-28
HXD Clamp General, Plastic Surgery Class 1 878.4800 2021-05-11
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2014-11-03
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2017-04-12
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-01-25
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2013-01-25
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2013-01-25
HTW Bit, Drill Orthopedic Class 1 888.4540 2013-01-24
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-02-11
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2016-12-15
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2021-06-07
HWT Template Orthopedic Class 1 888.4800 2013-01-25
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-01-25
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-09-06
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-09-06
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2023-09-06
HXL Mallet General, Plastic Surgery Class 1 878.4800 2013-01-25
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2018-07-17
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-07-17
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2018-07-17
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2013-01-28
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2026-02-12
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2026-02-12
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2026-02-12
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2026-02-12
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2026-02-12
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2021-06-15
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2013-01-25
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2013-01-25
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2013-10-23
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2013-01-25
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2013-01-24
HTF Curette General, Plastic Surgery Class 1 878.4800 2021-05-11
HXX Screwdriver Orthopedic Class 1 888.4540 2012-11-13
HTQ Broach Orthopedic Class 1 888.4540 2013-01-28
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-08-21
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2018-08-21
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2017-04-11
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2017-04-11
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-05-31
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-05-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-05-31
HTD Forceps General, Plastic Surgery Class 1 878.4800 2018-07-17
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-21
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2019-09-20
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2019-09-20
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2019-09-20
FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2017-07-19
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2021-06-15
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2021-06-15
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-06-15
HXW Bender Orthopedic Class 1 888.4540 2015-04-15
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2018-10-26
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2018-10-26
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-10-26
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2021-05-11
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2019-06-12
OCV Endoscope Holder Gastroenterology, Urology Class 2 876.1500 2019-06-12
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2021-05-17
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-05-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-08-09
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-07-17
HXY Brace, Drill Orthopedic Class 1 888.4540 2013-01-28
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-06-07
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2021-06-07
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-09-06
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2023-09-06
HWX Tap, Bone Orthopedic Class 1 888.4540 2017-04-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 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
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 1996-04-01

Official Correspondent

DARREN KLATT

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

THE CRETEX COMPANIES, 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
2183946 RMS CO. MINNEAPOLIS, MN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K032752 R&B Surgical Solutions, LLC R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM 2003-12-03
K062643 Life Spine KINETIC ANTERIOR CERVICAL PLATE 2006-11-16
K260601 Blue Belt Technologies, Inc. REAL INTELLIGENCE™ CORI™ 2026-03-26
K901338 Kirschner Medical Corp. KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM 1990-05-22
K030577 Stelkast Company PROVEN MODULAR TIBIAL TRAY 2003-03-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0036-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013 Medtronic Sofamor Danek USA Inc 2
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05 Zimmer Spine, Inc. 2
ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0041-2024 Blue Belt Technologies, Inc 2
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010009693. Last updated year: 2026. Please use registration number 3010009693 when referencing this establishment in official correspondence.
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