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

Orland Park, IL, US

ROG SPORTS MEDICINE, INC. appears in FDA device records in Orland Park, IL. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
5
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 5 510(k) clearances for Rog Sports Medicine, Inc. in 2011.

Clearances by year, as a table
510(k) clearance decisions for Rog Sports Medicine, Inc., by decision year
YearClearances
20115
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K113299ROG SUTURE ANCHORMBISubstantially Equivalent
K112991MODIFIED ROG SUTURE ANCHORMBISubstantially Equivalent
K111590ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHORMBISubstantially Equivalent
K110230ROG KNOTLESS SUTURE ANCHORMBISubstantially Equivalent
K110229ROG SUTURE ANCHOR 5.5MM, 2.9MMMBISubstantially Equivalent

Registered establishments

FDA registered establishments for Rog Sports Medicine, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30092278343009227834ROG SPORTS MEDICINE, INC.16450 104th Ave, Orland Park, IL 60467 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

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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What MDM checks, and what it does not

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