Data / Medical devices / United States / Teslake, Inc.

Teslake, Inc.: FDA-registered device maker in San Diego, CA, United States, 7 510(k) clearances

Name: Teslake, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Teslake, Inc. is registered with the FDA (registration 3016496998) in San Diego, CA, United States. It lists 9 device types. The FDA files 7 510(k) clearances under its listings, the newest dated June 6, 2024. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Teslake, Inc.

FDA registration number: 3016496998
Address: 17150 Via Del Campo Suite 308, San Diego, CA, United States, 92127
Owner or operator: Teslake, Inc. (10062341)
Roles: Specification developer
First device listed: January 14, 2020
Registered through: 2026
Brand names listed: Cervical Plate, Fixation Pin, Interbody Cage, MPS System, Modular Pedicle Screw (MPS) System

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Spinal Interlaminal	KWP	2	Specification developer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Specification developer	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Specification developer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Specification developer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Specification developer	accessdata.fda.gov
Pin, Fixation, Smooth	HTY	2	Specification developer	accessdata.fda.gov
Pin, Fixation, Threaded	JDW	2	Specification developer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 6, 2024	K240963	Spinal System	NKB	Substantially Equivalent	Teslake, Inc.	accessdata.fda.gov
December 26, 2019	K192768	Temporary Fixation Pins	JDW	Substantially Equivalent	Eisertech, LLC	accessdata.fda.gov
May 31, 2019	K190565	Cervical Plate	KWQ	Substantially Equivalent	Eisertech, LLC	accessdata.fda.gov
April 23, 2015	K140348	INTERBODY CAGE	MAX	Substantially Equivalent	Eisertech, LLC	accessdata.fda.gov
February 26, 2015	K142576	Spinal System	NKB	Substantially Equivalent	Eisertech, LLC	accessdata.fda.gov
April 6, 2012	K113170	CERVICAL PLATE	KWQ	Substantially Equivalent	Eisertech, LLC	accessdata.fda.gov
March 5, 2012	K113478	PLIF CAGE	MAX	Substantially Equivalent	Eisertech, LLC	accessdata.fda.gov

Compare with other makers

Updated June 6, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.