Device
The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have cranial deformities including plagiocephalic-, br...
Manufacturer
INVENT MEDICAL USA LLC
Model: Talee PostOp w/G1-Bi-Valve Opening DI: 00860013898090 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-04-28 Current Version: 2026-05-06
Description
The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads.
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: c643b732-2c2f-4e83-820e-eda52ed8a04a
Distribution Status: In Commercial Distribution
DUNS Number: 111474988
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: No
Serial Number Tracked: Yes
Manufacturing Date Tracked: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00860013898090
Type: Primary
Issuing Agency: GS1
GMDN
Code: 62265
Name: Cranial orthosis
Definition:
A 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.
FDA Product Codes
MVA
Orthosis, Cranial
OAN
Orthosis, Cranial, Laser Scan
Premarket Submissions
Submission Number: K220681
Supplement Number: 000