FDA.reportPublic FDA data

General Instruments

Primary DI
00811801033056
Brand
General Instruments
Company
ALPHATEC SPINE, INC.
Model
CI-10180-0800
Device description
Extended Graft Containment Slide - 8mm 0 degree
Published
2020-11-19
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811801033056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811801033056008118010330568118010330560811801033056

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic graft guideA device used to protect a graft during delivery to the site of implantation. The graft is inserted into the device, which allows introduction and manoeuvring into difficult sites [e.g., during delivery into the tibial and femoral tunnel during anterior cruciate ligament (ACL) reconstruction surgery]. It is typically tubular-shaped, made of sturdy materials (e.g., stainless steel, hard plastic) and comes in varying sizes. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190376509747SafeOp 3AIX118142026-03-24
00840180539521General InstrumentsCI-11843-082025-10-17
00840180541173General InstrumentsCI-11872-1002025-10-17
00840180541180General InstrumentsCI-11872-2002025-10-17
00840180541197General InstrumentsCI-11872-3002025-10-17
00840180541203General InstrumentsCI-11872-4002025-10-17
00190376633428Valence Robotic Navigation System525-10202026-02-26
00190376633435Valence Robotic Navigation System525-10302026-02-26
00190376633442Valence Robotic Navigation System525-1050-0952026-02-26
00190376633459Valence Robotic Navigation System525-1050-1252026-02-26
00190376633466Valence Robotic Navigation System525-1050-1502026-02-26
00190376633473Valence Robotic Navigation System525-10702026-02-26
00190376633480Valence Robotic Navigation System525-10902026-02-26
00190376633497Valence Robotic Navigation System525-10912026-02-26
00190376633503Valence Robotic Navigation System525-11002026-02-26
00190376633510Valence Robotic Navigation System525-11012026-02-26
00190376633527Valence Robotic Navigation System525-11102026-02-26
00190376633534Valence Robotic Navigation System525-10402026-02-26
00190376634340Valence Robotic Navigation System525-10412026-02-26
00190376643670Valence Robotic Navigation System525-10602026-02-26

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