FDA.reportPublic FDA data

Clarren Helmet

Primary DI
B15170905A0
Brand
Clarren Helmet
Company
ORTHOMERICA PRODUCTS, INC.
Model
709.05A
Catalog number
709.05A
Device description
The Clarren Helmet is a patient specific cranial orthosis that applies passive pressure to prominent regions of an infant’s cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic- shaped heads. The Clarren Helmet is made with an outer polypropylene plastic shell with a Plastizote inner liner and a chinstrap to help hold the helmet in place.
Published
2016-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVAOrthosis, Cranial
OANOrthosis, Cranial, Laser Scan

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVAOrthosis, CranialNeurology2
OANOrthosis, Cranial, Laser ScanNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021918000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021918000CLARREN HELMET (ORTHOMERICA)Orthomerica Products, Inc.2002-07-25OAN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B15170905A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cranial orthosisA custom-made helmet-like device intended to be worn on the head of an infant with an abnormal head shape (e.g., due to plagiocephaly, brachycephaly, scaphocephaly), or after craniosynostosis repair surgery, to apply pressure to the cranium and improve cranial symmetry/shape during growth over a period of months. It is made of durable materials (e.g., plastic, solid foam) and is designed with patient-specific characteristics (e.g., size, shape) based on head measurements (e.g., clinical pictures, 3-D scans, casts). It is typically worn during daily activities and sleep. This is a single-patient device that can be reapplied during the treatment period (reusable) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18004466770custserv@orthomerica.com

Regulatory Flags#

DUNS number
604405373
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B15170408A0St. Louis Band704.08A704.08A2016-08-22
B15170408PA0St. Louis Band704.08PA704.08PA2016-08-22
B15170908A0St. Louis Band709.08A709.08A2016-08-23
B15170908PA0St. Louis Band709.08PA709.08PA2016-08-23
B15176308A0St. Louis Band763.08A763.08A2016-08-23
B15176308PA0St. Louis Band763.08PA763.08PA2016-08-23
B15176210A0STARband® 3D762.10A762.10A2024-10-17
B15176310A0STARband® 3D763.10A763.10A2024-10-17
B15176410A0STARband® 3D764.10A764.10A2024-10-17
B15176510A0STARband® 3D765.10A765.10A2024-10-17
B15176610A0STARband® 3D766.10A766.10A2024-10-17
B15170309A0STARband® Plus703.09A703.09A2023-06-29
B15170309PA0STARband® Plus703.09PA703.09PA2023-06-29
B15170409A0STARband® Plus704.09A704.09A2023-06-29
B15170409PA0STARband® Plus704.09PA704.09PA2023-06-29
B15170909A0STARband® Plus709.09A709.09A2023-06-29
B15170909PA0STARband® Plus709.09PA709.09PA2023-06-29
B15170910A0STARband® 3D709.10A709.10A2023-06-29
B15176009A0STARband® Plus760.09A760.09A2023-06-29
B15176009PA0STARband® Plus760.09PA760.09PA2023-06-29

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Primary DI, Brand, Company table
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00860015811110Talee PostOpINVENT MEDICAL USA LLCOAN2026-04-28
00860015811110Talee PostOpINVENT MEDICAL USA LLCMVA2026-04-28
00860013026103Doc Band®Cranial Technologies, Inc.MVA2026-03-04
00860013026103Doc Band®Cranial Technologies, Inc.OAN2026-03-04
00860013026110Doc Band®Cranial Technologies, Inc.MVA2026-03-04
00860013026110Doc Band®Cranial Technologies, Inc.OAN2026-03-04
00860013898007TaleeINVENT MEDICAL USA LLCMVA2025-05-12
00860013898007TaleeINVENT MEDICAL USA LLCOAN2025-05-12
00860013898014TaleeINVENT MEDICAL USA LLCMVA2025-05-12
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