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FDA 510(k)

SYNTHES SYNAPSE TRANSCONNECTOR

K-Number: K090549 · 2009-05-21

ApplicantSynthes Spine
Decision Date2009-05-21
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES SYNAPSE TRANSCONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Synthes Spine. It received FDA 510(k) clearance on 2009-05-21 under 510(k) number K090549. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES SYNAPSE TRANSCONNECTOR?

SYNTHES SYNAPSE TRANSCONNECTOR is a medical device that received FDA 510(k) clearance on 2009-05-21. The listed applicant is Synthes Spine. The 510(k) number is K090549.

When did SYNTHES SYNAPSE TRANSCONNECTOR receive FDA 510(k) clearance?

SYNTHES SYNAPSE TRANSCONNECTOR received FDA 510(k) clearance on 2009-05-21, under 510(k) number K090549.

Who is the listed applicant for SYNTHES SYNAPSE TRANSCONNECTOR?

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

What is the FDA product code for SYNTHES SYNAPSE TRANSCONNECTOR?

The FDA product code for SYNTHES SYNAPSE TRANSCONNECTOR is KWP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Synthes Spine 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.

K122211SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTSK120838SYNTHES MATRIX SYSTEMK111048SYNTHES SCOUT TACK FIXATIONK120928SYNTHES MATRIX SYSTEMK120571SYNTHES USS CONNECTORK113149SYNTHES USS CONNECTORS

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Related Devices (Code: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, Inc.

Official Source

View on FDA Database →

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

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