Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010041499

FEI Number

3008647423

Entity Name

Tegra Medical

City/State/Country

Hernando, MS, US

Establishment Address

3414 Highway 51 S, Hernando, MS 38632, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Tegra Medical (Owner Number: 10042736)

Owner / Operator Contact Address

3414 Highway 51 South, Hernando, MS 38632, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-12-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-24
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-24
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-24
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2024-09-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-09-30
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-01-24
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-07-07
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-03-12
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-03-12
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2019-03-12
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-01-15
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2013-01-24
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2013-01-24
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2013-01-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-24
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-24
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-24
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2025-01-15
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-01-15
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-01-24
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-07-07
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2013-01-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2012-12-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2012-12-21
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-12-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2012-12-21
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-24
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2013-01-24
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-24
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2019-03-12
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-03-12
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2022-12-07
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2013-01-24
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-01-24
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2013-01-24
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2014-09-24
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2014-09-24
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2014-09-24
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2014-09-24
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2014-09-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2014-09-24
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2015-02-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-24
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-02-11
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-02-11
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-02-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-24
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-24
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2021-04-26
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2015-02-19
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-01-24
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-03-03

Official Correspondent

Timothy Chavez Jr.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tegra 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
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
K012175	Encore Orthopedics, Inc.	PASS SPINAL SYSTEM	2001-07-31
K963639	Acromed Corp.	ACROMED PEDICLE SCREW	1996-11-14
K032604	Co-Ligne AG	GII SPINAL FIXATION SYSTEM	2004-01-20

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-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010041499. Last updated year: 2026. Please use registration number 3010041499 when referencing this establishment in official correspondence.