Identity
- Trade Name
- Profile-ESP Bolster FDA UDI
- Generic Name
- Basic diagnostic x-ray system table, non-powered FDA UDI
- Device Name
- The Profile-ESP Bolster device is an optional patient positioning accessory for use within the Profile-ESP workflow of the VMA System. The patient's pelvis is secured while performing the indicated spinal flexion and extension bending. The dimensions are approximately 40-47” wide (adjustable width), 24” deep, 42-58” tall (adjustable height). Weight is approximately 98 lbs. (44 kg). FDA UDI
- Model / Reference
- 3.0 FDA UDI
- Description
- The Profile-ESP Bolster device is an optional patient positioning accessory for use within the Profile-ESP workflow of the VMA System. The patient's pelvis is secured while performing the indicated spinal flexion and extension bending. The dimensions are approximately 40-47” wide (adjustable width), 24” deep, 42-58” tall (adjustable height). Weight is approximately 98 lbs. (44 kg). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00868579000261 FDA UDI
- FDA Product Code
- INW FDA UDI
- GMDN Term
- Basic diagnostic x-ray system table, non-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Basic diagnostic x-ray system table, non-powered
Profile-ESP Bolster by Ortho Kinematics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Ortho Kinematics, Inc.
Sources (1)
- FDA UDI 803652db-ebdf-43a3-9b6f-ec67596884d8 33 fields · synced Jun 1, 2026