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FDA 510(k)

Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base

K-Number: K172644 · 2017-11-03

ApplicantStimwave Technologies Incorporated
Decision Date2017-11-03
Product CodeGZB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base is a medical device manufactured by Stimwave Technologies Incorporated. It received FDA 510(k) clearance on 2017-11-03 under approval number K172644. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base?

Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base is a medical device that received FDA 510(k) clearance on 2017-11-03. It is manufactured by Stimwave Technologies Incorporated. The 510(k) number is K172644.

When was Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base approved by the FDA?

Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base received FDA 510(k) clearance on 2017-11-03, under approval number K172644.

What company makes Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base?

Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base is manufactured by Stimwave Technologies Incorporated.

What is the FDA product code for Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base?

The FDA product code for Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base is GZB.

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

Other Devices by Stimwave Technologies Incorporated

K162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit K160600Freedom Spinal Cord Stimulator System K170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit K180981Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit K182720Freedom Spinal Cord Stimulator (SCS) System

Related Devices (Code: GZB)

K162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitStimwave Technologies Incorporated K160600Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated K170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitStimwave Technologies Incorporated K180981Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitStimwave Technologies Incorporated K191466SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc. K190960Nalu Lead Blank (50cm)Boston Scientific Neuromodulation

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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