510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OSSIO, Ltd.

Caesarea, IL

OSSIO , Ltd. appears in FDA device records in Caesarea, IL. FDA records list 20 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
20
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 20 510(k) clearances for OSSIO, Ltd. between 2019 and 2026. The busiest year on record is 2020, with 3. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for OSSIO, Ltd., by decision year
YearClearances
20191
20203
20212
20223
20233
20243
20253
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K254077OSSIOfiber® Threaded Trimmable Fixation NailHWCSubstantially Equivalent
K254055OSSIOfiber® Suture AnchorMAISubstantially Equivalent
K252022OSSIOfiber® Interference ScrewMAISubstantially Equivalent
K251309OSSIOfiber® Suture AnchorMAISubstantially Equivalent
K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmMAISubstantially Equivalent
K241932OSSIOfiber® Compression StapleMNUSubstantially Equivalent
K241277OSSIOfiber® Threaded Trimmable Fixation NailHWCSubstantially Equivalent
K233198OSSIOfiber® Threaded Trimmable Fixation NailsHWCSubstantially Equivalent
K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation NailHTYSubstantially Equivalent
K233302OSSIOfiber® Compression StapleMNUSubstantially Equivalent
K230750OSSIOfiber® Cannulated Trimmable Fixation NailHTYSubstantially Equivalent
K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmHWCSubstantially Equivalent
K213415OSSIOfiber Suture AnchorMAISubstantially Equivalent
K212594OSSIOfiber® StapleMNUSubstantially Equivalent
K213596OSSIOfiber Compression Screw, 3.5mmHWCSubstantially Equivalent
K203465OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated DesignHTYSubstantially Equivalent
K201803OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation ImplantHTYSubstantially Equivalent
K193660OSSIOfiber™ Compression ScrewsHWCSubstantially Equivalent
K190652OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation ImplantHTYSubstantially Equivalent
K181180OSSIO™ Pin Product FamilyHTYSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain