Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016676864

FEI Number

3016676864

Entity Name

NOVUS MANUFACTURING SOLUTIONS

City/State/Country

Murfreesboro, TN, US

Establishment Address

427 N. Front street, Murfreesboro, TN 37130, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Novus Manufacturing Solutions (Owner Number: 10066039)

Owner / Operator Contact Address

427 N. Front street, Murfreesboro, TN 37130, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ATL Suture Anchor Secondary QR Target Digitizer Probe Digitizer Handle Lateral QR Target Hip Sextant Base Hip Sextant Anterior ASIS Drill Guide ASIS Cannula Clamp Foot Anterior Base Point Guide Pin Extender ASIS Cannula Clamp Taper 6mm Black Paddle Scraper 7mm Black Paddle Scraper 8.5mm Primus Cannulated Tap 13mm Black Paddle Scraper Quick Lock Screwdriver Handle LOTUS 240mm Rod Template 8.5mm Navigated Cannulated Tap T20 Driver - 10" Long Non Cannulated Lucent XP ARC Inserter OMEGALIF Disc Brush Bone Funnel 9mm Black Paddle scraper 4.5mm Primus Cannulated Tap 5.5mm Primus Cannulated Tap 8mm Black Paddle Scraper 14mm Black Paddle Scraper 6.5mm Primus Cannulated Tap 5mm Black Paddle Scraper 2.5mm Self Retaining AO Screwdriver 10mm Black Paddle Scraper 11mm Black Paddle Scraper 4.5mm Navigated Cannulated Tap Primus Singlepass Ratchet T-Handle Primus Clip-On Reducer Anterior Access Guide, SS 6.5mm Navigated Cannulated Tap 7mm X 6mm TLIF Wedge 7.5 Primus Cannulated Tap 12mm Black Paddle Scraper Posterior Access Guide, SS Extended-Tab Counter Torque 5.5mm Navigated Cannulated Tap 7.5mm Navigated Cannulated Tap Base Point Cannula Needle Knob Drill Guide Direction Pin Tip Needle with Cap Needle Cannula

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-04-11
SBF	Orthopedic Augmented Reality	Neurology	Class 2	882.4560	2025-12-17
OSF	Patient Specific Manual Orthopedic Stereotaxic System	Neurology	Class 2	882.4560	2025-12-17
OSF	Patient Specific Manual Orthopedic Stereotaxic System	Neurology	Class 2	882.4560	2025-12-17
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2025-12-19
OSF	Patient Specific Manual Orthopedic Stereotaxic System	Neurology	Class 2	882.4560	2025-12-17

Official Correspondent

Carrie Bayne

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Novus Manufacturing Solutions

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02
K231867	Paragon 28, Inc.	Grappler Suture Anchor System	2023-08-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016676864. Last updated year: 2026. Please use registration number 3016676864 when referencing this establishment in official correspondence.