FDA.reportPublic FDA data

Oakworks Medical

Primary DI
00817463022537
Brand
Oakworks Medical
Company
OAKWORKS, INC.
Model
Spine Positioning System (SPS) II
Device description
For use in diagnostic and therapeutic procedures of the spine. It is intended to be used by a healthcare professional solely for the purpose of aiding in patient positioning and comfort during non-surgical imaging or spinal injection procedures
Published
2016-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IZZTable, Radiographic, Non-Tilting, Powered
KXHCradle, Patient, Radiologic
MMZTable, Cystometric, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZZTable, Radiographic, Non-Tilting, PoweredRadiology2
KXHCradle, Patient, RadiologicRadiology1
MMZTable, Cystometric, ElectricGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817463022537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817463022537008174630225378174630225370817463022537

GMDN Terms#

Term, Definition table
TermDefinition
Head/neck procedure positionerA noninvasive device consisting of fixed or adjustable elements (e.g., frame, board, multi-jointed structure) designed to ensure adequate support, positioning and immobilization of the patient's head, neck, and cervical spine during intraoperative procedures (e.g., cervical spine or brain surgery) or diagnostic imaging (e.g., dental x-ray procedures). It is typically mounted on an operating/examination table and allows adjustment of the height and angle of the head. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
130256837
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817463026719Oakworks MedicalPT100 Table2023-08-08
00817463027242Oakworks MedicalProcedure Chair Prone Face Rest System2023-12-13
00817463026436Oakworks MedicalUrology Table Drape2023-12-06
00817463027129Oakworks MedicalDetachable Arm Board2023-12-06
00817463027136Oakworks MedicalPowerline Table Extender2023-12-06
00817463027143Oakworks MedicalPowerline Table Extender2023-12-06
00817463027174Oakworks MedicalPatient Strap - Ultrasound EA2023-12-06
00817463026870Oakworks MedicalPT300 Table2023-10-03
00817463026887Oakworks MedicalPT300 Table2023-10-03
00817463025378Oakworks MedicalUltrasound EA General 2 Section Table or Echocardi2023-10-02
00817463025385Oakworks MedicalUltrasound EA General 2 Section Table or Multi-Spe2023-10-02
00817463025408Oakworks MedicalUltrasound EA General 2 Section Table2023-10-02
00817463025460Oakworks MedicalUltrasound EA General 3 Section Table2023-10-02
00817463025477Oakworks MedicalUltrasound EA General 3 Section Table or Echocard2023-10-02
00817463026894Oakworks MedicalPT300 Table2023-10-02
00817463026931Oakworks MedicalPT400 Table2023-10-02
00817463026948Oakworks MedicalPT400 Table2023-10-02
00817463026955Oakworks MedicalPT400 Table2023-10-02
00817463026979Oakworks MedicalPT400M Table2023-10-02
00817463025484Oakworks MedicalUltrasound EA General 3 Section Table or Multi-Spe2023-09-29

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