FDA.report

Lateral Patient Positioning System

Primary DI
00190376484136
Brand
Lateral Patient Positioning System
Company
ALPHATEC SPINE, INC.
Model
181-300
Device description
Thoracic Anterior Paddle
Published
2023-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CCXSUPPORT, PATIENT POSITION

Product Code Classifications

CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190376484136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376484136001903764841361903764841360190376484136

GMDN Terms

TermDefinition
Spinal surgery positioning boardA device comprised of a supportive foundation and adjustable positioning elements designed to be attached to an operating table to enable correct positioning and immobilization of a patient during surgical procedures involving the spine (e.g., thoracolumbrosacral surgery, disc decompression). It supports the patient in the prone or supine position providing a close approximation to a patient's natural lumbar lordosis while facilitating reduced abdominal compression. It typically consists of a base plate/board made of durable materials (e.g., metal, carbon fibre) to which other devices are attached (e.g., intraoperative positioners, headrest, x-ray cassette). This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(760)431-9286Regulatory@alphatecspine.com

Regulatory Flags

DUNS number
602465783
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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