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

Orlando, FL, US

ORTHOMERICA PRODUCTS, INC. appears in FDA device records in Orlando, FL. FDA records list 21 510(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
21
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 21 510(k) clearances for Orthomerica Products, Inc. between 2000 and 2024. The busiest year on record is 2008, with 3. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Orthomerica Products, Inc., by decision year
YearClearances
20001
20011
20022
20083
20091
20131
20143
20153
20161
20181
20212
20231
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K240466STARband 3DOANSubstantially Equivalent
K223238STARband 3DMVASubstantially Equivalent
K211376STARbandOANSubstantially Equivalent
K203098STARband, STARlight, St. Louis BandOANSubstantially Equivalent
K180109STARband, STARlight, St. Louis BandOANSubstantially Equivalent
K161138St. Louis BandOANSubstantially Equivalent
K151979STARband, STARlightOANSubstantially Equivalent
K151147STARband, STARlightOANSubstantially Equivalent
K142141STARBAND, STARLIGHTOANSubstantially Equivalent
K141842STARBAND, STARLIGHTMVASubstantially Equivalent
K140353STARBAND AND STARLIGHTMVASubstantially Equivalent
K133250STARLIGHTOANSubstantially Equivalent
K124023STARBANDOANSubstantially Equivalent
K090587STARLIGHTOANSubstantially Equivalent
K082950STARBANDOANSubstantially Equivalent
K082945STARLIGHTOANSubstantially Equivalent
K081994STARLIGHTOANSubstantially Equivalent
K021918CLARREN HELMET (ORTHOMERICA)OANSubstantially Equivalent
K021207STARLIGHTOANSubstantially Equivalent
K011350STARBAND CRANIAL ORTHOSISOANSubstantially Equivalent
K001167OPI BANDMVASubstantially Equivalent

Registered establishments

FDA registered establishments for Orthomerica Products, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10581521000222089ORTHOMERICA PRODUCTS, INC.6333 N Orange Blossom Trl, ORLANDO, FL 32810 US2026and 10 more, listed in full below

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

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