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FDA 510(k)

Testa TP Pivoting Spacer System

K-Number: K243816 · 2025-06-27

ApplicantSpine Wave, Inc.
Decision Date2025-06-27
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Testa TP Pivoting Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Spine Wave, Inc.. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K243816. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Testa TP Pivoting Spacer System?

Testa TP Pivoting Spacer System is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Spine Wave, Inc.. The 510(k) number is K243816.

When did Testa TP Pivoting Spacer System receive FDA 510(k) clearance?

Testa TP Pivoting Spacer System received FDA 510(k) clearance on 2025-06-27, under 510(k) number K243816.

Who is the listed applicant for Testa TP Pivoting Spacer System?

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

What is the FDA product code for Testa TP Pivoting Spacer System?

The FDA product code for Testa TP Pivoting Spacer System is MAX.

Other records listing Spine Wave, 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.

K260286Dynamo™ Spinal Cement; Salvo® Spine SystemK261159Exceed® Biplanar Expandable Interbody SystemK251131Annex® 2 Adjacent Level SystemK243514Salvo® Robotic Navigation InstrumentsK240685Salvo® Spine SystemK231275Exceed™ Biplanar Expandable Interbody System

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Related Devices (Code: MAX)

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.

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, 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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