Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009957608

FEI Number

3009957608

Entity Name

ZIGG DESIGN LLC

City/State/Country

Nibley, UT, US

Establishment Address

1665 West Nibley Parkway, Nibley, UT 84321, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ZIGG DESIGN LLC (Owner Number: 10042345)

Owner / Operator Contact Address

1665 West Nibley Parkway, Nibley, UT 84321, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Saber-C System Unknown name, manufacturing components for various OEMs Drill, Straight Audere C Trial Head Audere Screw Handle Screwdriver Mallet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-01-03
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-03
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2025-01-03
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-11-16
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2025-01-03
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2017-11-21
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2017-11-21
HWT	Template	Orthopedic	Class 1	888.4800	2025-01-03
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-11-21
HXC	Wrench	Orthopedic	Class 1	888.4540	2025-01-03
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2025-01-03
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2025-01-03

Official Correspondent

Gordon Baker

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ZIGG DESIGN LLC

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
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09
K122085	Omni Surgical, LP Dba Spine360	STINGRAY CERVICAL CAGE	2012-10-17
K120275	Synthes (Usa), LLC	SYNTHES ACIS/VERTEBRAL SPACER CR	2012-05-25
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

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-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.

Similar Registrations

Registration Number	Establishment Name	Location
3021588295	XYRESIC LLC	Jackson, MI, US
3036496433	SPECTRUM SPINE INC	Jasper, GA, US
3027726367	HAPPE SPINE	Grand Rapids, MI, US
3027201862	XCIX DESIGN, LLC	Richmond, UT, US
3017936978	CARLSMED, INC.	Carlsbad, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009957608. Last updated year: 2026. Please use registration number 3009957608 when referencing this establishment in official correspondence.