VersaTap™ Suture Anchor (ADP050) +4 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242296

Identifiers

510(k) Number: K242296 FDA 510(k)
FDA Product Code: MBI FDA 510(k)
Models / Variants: VersaTap™ Suture Anchor (ADP050) FDA 510(k)
VersaPEEK™ Suture Anchor (APP002) FDA 510(k)
MicroTi™ Suture Anchor (ATP003-M) FDA 510(k)
VersaLat™ Ti Suture Anchor (ADP021-TI) FDA 510(k)
VersaLat™ Suture Anchor (ADP021-PK) FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 888.3040 FDA 510(k)
Regulation Number: 888.3040 FDA 510(k)
Advisory Committee: Orthopedic FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

VersaTap™ Suture Anchor (ADP050) +4 more models by Ortho-Design (pty) Ltd — Class II — FDA_510K — listed in FDA 510(k) — 5 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K242296	Class II	Active

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Manufacturer

Manufacturer: Ortho-Design (pty) Ltd
FDA Applicant: Ortho-Design (Pty), Ltd.

Sources (1)

FDA 510(k) K242296 24 fields · synced Jun 18, 2026