FDA.report

Ambassador Cervical Plate System

Primary DI
00840996153201
Brand
Ambassador Cervical Plate System
Company
Choice Spine, LP
Model
05-109-14-0000
Device description
AMBASSADOR,SGL BRL DRILLGUIDE
Published
2017-09-01
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
false

Related Records

Contact Domains

Product Codes

CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840996153201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840996153201008409961532018409961532010840996153201

GMDN Terms

TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and 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).

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(865)246-3333info@choicespine.net

Regulatory Flags

DUNS number
078293017
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
true

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00840996150712Acapella One05-099-05-14082024-02-24
00840996150729Acapella One05-099-05-14092024-02-24
00840996150736Acapella One05-099-05-14102024-02-24
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
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