Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016496998

FEI Number

3016496998

Entity Name

TESLAKE, INC.

City/State/Country

San Diego, CA, US

Establishment Address

17150 Via Del Campo, Suite 308, San Diego, CA 92127, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Teslake, Inc. (Owner Number: 10062341)

Owner / Operator Contact Address

7 Beechbrook Lane, Rochester, NY 14625, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190565

PMA Number

N/A

All Registered Proprietary Names

Interbody Cage Modular Pedicle Screw (MPS) System Interbody Cage Cervical Plate MPS System Cervical Plate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-01-14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-30
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-30
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-30
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-30
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-01-14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-01-14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-01-14
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2020-01-14
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2020-01-14
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-01-14
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2020-01-14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-01-14

Official Correspondent

Lukas Eisermann

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Teslake, Inc.

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
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09
K200084	Zavation Medical Products, LLC	Zavation IBF System	2020-10-19

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-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016496998. Last updated year: 2026. Please use registration number 3016496998 when referencing this establishment in official correspondence.