Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1531174

FEI Number

3002993297

Entity Name

NORWOOD MEDICAL LLC

City/State/Country

Dayton, OH, US

Establishment Address

2122 Winners Circle, Dayton, OH 45404, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Norwood Medical (Owner Number: 10042115)

Owner / Operator Contact Address

2122 Winners Circle, Dayton, OH 45404, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Locking Drill Guide 2.2mm DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES Zimmer Persona Knee System 8mm Assist Cannula, 12mm Assist Cannula Endo Wrist Stapler 45 and Stapler 45 Reloads da Vinci Surgical System, Model IS5000 Zimmer Trabecular Metal Total Ankle TI X25 Variable Connector Setscrew Continuum, Trilogy IT Acetabular System Provisional Liner Locking Screw Zimmer Segment System Trabecular Metal Proximal Tibial Component Monoaxial Screw 5.5 x 5 X 30mm Monoaxial Screw 5.5 x 5 X 35mm Monoaxial Screw 5.5 x 6 X 50mm Single Hole Staple Monoaxial Screw 5.5 x 7 X 60mm Monoaxial Screw 5.5 x 6 X 55mm Dual Hole Staple, Rostral, Small Dual Hole Staple, Caudal, Medium Monoaxial Screw 5.5 x 6 X 27.5mm Dual Hole Staple, Rostral, Medium Monoaxial Screw 5.5 x 6 X 45mm Monoaxial Screw 5.5 x 7 X 45mm Crossconnector 13mm Monoaxial Screw 5.5 x 6 X 37.5mm Crossconnector 16mm Monoaxial Screw 5.5 x 5 X 40mm Monoaxial Screw 5.5 x 6 X 22.5mm Crossconnector 18mm Crossconnector 15mm Crossconnector Set Screw Crossconnector 14mm Monoaxial Screw 5.5 x 6 X 40mm Monoaxial Screw 5.5 x 7 X 30mm Monoaxial Screw 5.5 x 7 X 50mm Monoaxial Screw 5.5 x 7 X 25mm Dual Hole Staple, Caudal, Small Monoaxial Screw 5.5 x 6 X 32.5mm Monoaxial Screw 5.5 x 7 X 35mm Monoaxial Screw 5.5 x 6 X 30mm Monoaxial Screw 5.5 x 6 X 35mm Monoaxial Screw 5.5 x 7 X 40mm Dual Hole Staple, Rostral, Large

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-01-07
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2020-08-26
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-11-06
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-03
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-03
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-03
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-01-03
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-03
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-02
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-12-07
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-01-07
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-01-04
HWB	Extractor	Orthopedic	Class 1	888.4540	2024-05-31
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2013-01-07
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-09-23
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-11-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-11-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-11-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-11-29
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-11-29
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2024-05-31
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2025-04-11
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2025-04-11
HXC	Wrench	Orthopedic	Class 1	888.4540	2013-01-04
HWA	Impactor	Orthopedic	Class 1	888.4540	2013-01-07
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2025-04-11
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2025-04-11
HWJ	Awl	Orthopedic	Class 1	888.4540	2013-01-07
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-01-13
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-13
PGM	Growing Rod System	Orthopedic	Class 2	888.3070	2026-01-13
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-01-13
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2026-01-13
JDN	Implant, Fixation Device, Spinal	Orthopedic	Class 2	888.3060	2026-01-13
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2012-12-07
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-01-04
HWT	Template	Orthopedic	Class 1	888.4800	2013-01-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-02
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-01-02
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-02
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-02
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-02
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-02
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-02
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-02
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-02
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-01-02
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-06-19
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2018-06-19
OQH	Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3350	2018-06-19
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2018-06-19
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2018-06-19
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2018-06-19
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2012-12-07
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2012-12-07
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2012-12-07
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2012-12-07
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2012-12-07
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2012-12-07
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2012-12-07
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-12-07
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2013-01-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-01-02
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-02
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-02
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-02
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-02
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2023-12-18
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2013-01-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-02
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-03
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-03
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-03
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-03

Official Correspondent

Jennifer Kleinwaechter

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Norwood Medical

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
K032604	Co-Ligne AG	GII SPINAL FIXATION SYSTEM	2004-01-20
K964304	Osteonics Corp.	OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY	1997-01-17
K012175	Encore Orthopedics, Inc.	PASS SPINAL SYSTEM	2001-07-31
K963639	Acromed Corp.	ACROMED PEDICLE SCREW	1996-11-14
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011	Zimmer Inc.	2	SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1531174. Last updated year: 2026. Please use registration number 1531174 when referencing this establishment in official correspondence.