Identity
- Trade Name
- STARband® FDA UDI
- Generic Name
- Cranial orthosis FDA UDI
- Device Name
- The STARband® is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The STARband® is made with an outer copolymer plastic shell and an inner liner made of pelite polyethylene foam or Aliplast foam (closed cell polyethylene). It utilizes a side opening design and is held in place by a Velcro® strap across the side opening. FDA UDI
- Model / Reference
- 704A FDA UDI
- Description
- The STARband® is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The STARband® is made with an outer copolymer plastic shell and an inner liner made of pelite polyethylene foam or Aliplast foam (closed cell polyethylene). It utilizes a side opening design and is held in place by a Velcro® strap across the side opening. FDA UDI
Identifiers
- Catalog Number
- 704A FDA UDI
- Primary DI / UDI-DI
- B151704A0 FDA UDI
- 510(k) Number
- K011350 FDA UDI
- FDA Product Code
- MVA FDA UDI
- GMDN Term
- Cranial orthosis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5970 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cranial orthosis
STARband® by Orthomerica Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cranial orthosis.
- Hanger Cranial Band — HANGER NATRIONAL LABORATORIES LLC · Class II
- Talee PostOp — INVENT MEDICAL USA, LLC · Class II
- MyCRO Band — OTTO BOCK HEALTHCARE · Class II
- Boston Band — Boston Brace International, Inc. · Class II
- Michigan Cranial Reshaping Orthosis — DANMAR PRODUCTS, INC. · Class II
- Doc Band® — CRANIAL TECHNOLOGIES, INC. · Class II
- MyCRO Band — OTTO BOCK HEALTHCARE · Class II
- MyCRO Band — OTTO BOCK HEALTHCARE · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthomerica Products, Inc.
Sources (1)
- FDA UDI 7dc63444-7921-4fa4-b16d-3ce219cff7a6 36 fields · synced May 31, 2026