SAS MIS Pelvic Incidence Rods
Summary
Spinal Alignment Solutions, Inc. received 510(k) clearance for SAS MIS Pelvic Incidence Rods, a NKB device. Cleared on 2026-09-30.
Details
Source
510(k) Clearance
External ID
K263172
Action Date
2026-09-30
Status
Special
Category
device
Product Code
NKB
Product Description
SAS MIS Pelvic Incidence Rods. Product code: NKB.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 518 device clearances issued this month. Spinal Alignment Solutions, Inc. has received 2 total clearances in our database.
Spinal Alignment Solutions, Inc. has 2 FDA actions in our database, including 2 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 Spinal Alignment Solutions, Inc. have FDA actions?
Spinal Alignment Solutions, Inc. has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K263172" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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