Permatage XT Settable Bone Putty
Summary
Orthocon, Inc. received 510(k) clearance for Permatage XT Settable Bone Putty, a GXP device. Cleared on 2026-06-15.
Details
Source
510(k) Clearance
External ID
K261265
Action Date
2026-06-15
Status
Special
Category
device
Product Code
GXP
Product Description
Permatage XT Settable Bone Putty. Product code: GXP.
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. Orthocon, Inc. has received 18 total clearances in our database.
Orthocon, Inc. has 18 FDA actions in our database, including 18 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 Orthocon, Inc. have FDA actions?
Orthocon, Inc. has 18 FDA actions in our database, including 0 recalls and 18 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K261265" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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