Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant
Summary
Atlas Spine, Inc. received 510(k) clearance for Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant, a PLR device. Cleared on 2026-07-15.
Details
Source
510(k) Clearance
External ID
K252822
Action Date
2026-07-15
Status
Traditional
Category
device
Product Code
PLR
Product Description
Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant. Product code: PLR.
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 365 device clearances issued this month. Atlas Spine, Inc. has received 4 total clearances in our database.
Atlas Spine, Inc. has 4 FDA actions in our database, including 4 clearances.
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 Atlas Spine, Inc. have FDA actions?
Atlas Spine, Inc. has 4 FDA actions in our database, including 0 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K252822" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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