FDA.report

Ambassador

Primary DI
10885862269232
Brand
Ambassador
Company
Choice Spine, LP
Model
05-100-03-0054
Catalog number
05-100-03-0054
Published
2016-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications

CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885862269232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088586226923210885862269232

GMDN Terms

TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length54Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
078293017
Device count
1
DM exempt
false
Premarket exempt
false
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
true

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00840996150712Acapella One05-099-05-14082024-02-24
00840996150729Acapella One05-099-05-14092024-02-24
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00840996150743Acapella One05-099-05-14112024-02-24
00840996150750Acapella One05-099-05-14122024-02-24
00840996150767Acapella One05-099-05-16052024-02-24
00840996150774Acapella One05-099-05-16062024-02-24
00840996150781Acapella One05-099-05-16072024-02-24
00840996150798Acapella One05-099-05-16082024-02-24

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00840283402197VyPlate™VY SPINE LLCKWQ2026-03-19
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