# Orthomerica Products, Inc.

- Location (FDA's records): Orlando, FL
- FDA decisions: 21 (2000–2024): 21 510(k) clearances
- Product codes: OAN (17), MVA (4)
- Predicates its devices cite: 27 (22 its own); citations of its devices by later devices: 39 (22 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Brace Intl., Inc.: 2 (https://510kreport.com/company/boston-brace-intl)
- Cranial Technologies, Inc.: 1 (https://510kreport.com/company/cranial-technologies)
- Orthotic & Prosthetic Lab, Inc.: 1 (https://510kreport.com/company/orthotic-prosthetic-lab)
- Biosculptor Corporation: 1 (https://510kreport.com/company/biosculptor)

## Firms that cite its devices most
- Boston Brace Intl., Inc.: 3 (https://510kreport.com/company/boston-brace-intl)
- Otto Bock Healthcare LP: 2 (https://510kreport.com/company/otto-bock-healthcare)
- Orthotic Care Services, Llp: 2 (https://510kreport.com/company/orthotic-care-services)
- Orthotic & Prosthetic Lab, Inc.: 1 (https://510kreport.com/company/orthotic-prosthetic-lab)
- Becker Orthopedic Appliance Co.: 1 (https://510kreport.com/company/becker-orthopedic-appliance)
- Lerman & Son: 1 (https://510kreport.com/company/lerman-son)
- Headstart, Ltd.: 1 (https://510kreport.com/company/headstart)
- Invent Medical USA, LLC: 1 (https://510kreport.com/company/invent-medical-usa)

## Its most-cited devices
- K011350: Starband Cranial Orthosis (2001), cited by 7
- K001167: Opi Band (2000), cited by 5
- K082950: Starband (2008), cited by 4
- K180109: STARband, STARlight, St. Louis Band (2018), cited by 3
- K151979: STARband, STARlight (2015), cited by 3
- K140353: Starband and Starlight (2014), cited by 2

## Recent decisions
- K240466: STARband 3D (Mar 15, 2024)
- K223238: STARband 3D (Apr 20, 2023)
- K211376: STARband (Aug 17, 2021)
- K203098: STARband, STARlight, St. Louis Band (Apr 27, 2021)
- K180109: STARband, STARlight, St. Louis Band (Mar 1, 2018)
- K161138: St. Louis Band (Jul 20, 2016)
- K151979: STARband, STARlight (Sep 18, 2015)
- K151147: STARband, STARlight (Jul 1, 2015)

Source page: https://510kreport.com/company/orthomerica-products