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FDA 510(k)

TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT

K-Number: K032891 · 2004-01-15

ApplicantTrans1, Inc.
Decision Date2004-01-15
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Trans1, Inc.. It received FDA 510(k) clearance on 2004-01-15 under 510(k) number K032891. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT?

TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT is a medical device that received FDA 510(k) clearance on 2004-01-15. The listed applicant is Trans1, Inc.. The 510(k) number is K032891.

When did TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT receive FDA 510(k) clearance?

TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT received FDA 510(k) clearance on 2004-01-15, under 510(k) number K032891.

Who is the listed applicant for TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT?

The FDA 510(k) record lists Trans1, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT?

The FDA product code for TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT is HRX.

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Other records listing Trans1, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K123997TRANS1LATERAL INTERBODY FUSION SYSTEMK040426TRANS1 AXIAL FIXATION SYSTEM

Related Devices (Code: HRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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