TranS1

Magnolia, TX, US

TranS1 appears in FDA device records in Magnolia, TX. FDA records list 5 510(k) clearances between 2004-01-15 and 2019-11-20, no PMA records and one registered establishment. As of 2026-09-10, FDA records show no recalls for this company, and at least one establishment registration is current.

510(k) clearances: 5
PMA records: 0
Recall records: 0
Registered establishments: 1

510(k) clearance history

FDA records hold 5 510(k) clearances for TranS1 between 2004 and 2019. The busiest year on record is 2004, with 2. The most recent is 2019, with 2.

Clearances by year, as a table

510(k) clearance decisions for TranS1, by decision year
Year	Clearances
2004	2
2013	1
2019	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K192792	TranS1 AxiaLIF Plus System	KWQ	Substantially Equivalent	2019-11-20
K191791	TranS1 Interbody Fusion System	MAX	Substantially Equivalent	2019-09-25
K123997	TRANS1LATERAL INTERBODY FUSION SYSTEM	MAX	Substantially Equivalent	2013-04-01
K040426	TRANS1 AXIAL FIXATION SYSTEM	KWQ	Substantially Equivalent	2004-12-17
K032891	TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT	HRX	Substantially Equivalent	2004-01-15

Registered establishments

FDA registered establishments for TranS1, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3011302058	3011302058	TranS1	32938 Tamina Rd., Magnolia, TX 77354 US	2026	HRX HTY HWC JDR KWQ LXH MRW NBH

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain