Data / Medical devices / United States / TranS1

TranS1: FDA-registered device maker in Magnolia, TX, United States, 8 510(k) clearances

Name: TranS1 FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

TranS1 is registered with the FDA (registration 3011302058) in Magnolia, TX, United States. It lists 8 device types. The FDA files 8 510(k) clearances under its listings, the newest dated November 20, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011302058
Address: 32938 Tamina Rd. Suite 203, Magnolia, TX, United States, 77354
Owner or operator: TranS1, LLC (10048027)
Roles: Complaint file establishment, Specification developer
First device listed: April 6, 2015
Registered through: 2026
Brand names listed: AxiaLIF+

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Arthroscope	HRX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Pin, Fixation, Smooth	HTY	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Facet Screw Spinal Device	MRW	U	Complaint file establishment, 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
November 20, 2019	K192792	TranS1 AxiaLIF Plus System	KWQ	Substantially Equivalent	Trans1	accessdata.fda.gov
November 7, 2012	K121277	Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE	HWC	Substantially Equivalent	Z-Medical GmbH & Co. KG	accessdata.fda.gov
January 21, 2010	K092124	AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II	KWQ	Substantially Equivalent	Trans1 Incorporated	accessdata.fda.gov
April 28, 2008	K073643	TRANS1 AXIALIF 2-LEVEL OR II SYSTEM	KWQ	Substantially Equivalent	Trans1 Incorporated	accessdata.fda.gov
March 11, 2008	K073515	TRANS1 FACET SCREW	MRW	Substantially Equivalent	Trans1 Incorporated	accessdata.fda.gov
January 11, 2008	K073514	TRANS1 AXIAL FIXATON SYSTEM	KWQ	Substantially Equivalent	Trans1 Incorporated	accessdata.fda.gov
September 26, 2005	K051856	TRANS1 FACET SCREWS	MRW	Substantially Equivalent	Trans1 Incorporated	accessdata.fda.gov
June 14, 2005	K050965	TRANS1 AXIALIF SYSTEM	KWQ	Substantially Equivalent	Trans1 Incorporated	accessdata.fda.gov

Compare with other makers

Updated November 20, 2019. 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.