Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System
Summary
Orthofix Medical, Inc. received 510(k) clearance for Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System, a MAX device. Cleared on 2024-06-20.
Details
Source
510(k) Clearance
External ID
K240830
Action Date
2024-06-20
Status
Traditional
Category
device
Product Code
MAX
Product Description
Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System. Product code: MAX.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Orthofix Medical, Inc. have FDA actions?
This is the only FDA action we have on record for Orthofix Medical, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K240830" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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