FDA.reportPublic FDA data

General Instruments

Primary DI
00811801039966
Brand
General Instruments
Company
ALPHATEC SPINE, INC.
Model
CI-10591
Device description
Temporary Locking Extended Tab Driver
Published
2020-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXCMONITOR, PRESSURE, INTRACOMPARTMENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXCMonitor, Pressure, IntracompartmentalUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811801039966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811801039966008118010399668118010399660811801039966

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw or setscrew, whilst providing a torque-limiting function to ensure that the screw is not over tightened, during an orthopaedic procedure. The device is typically made of metal/synthetic material (e.g., polysulphone) and may have a T-shaped handle grip. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190376649474CONTOUR3DAIX761032026-09-25
00190376652313CONTOUR3DAIX761012026-09-25
00190376652320CONTOUR3DAIX761022026-09-25
00190376652337CONTOUR3DAIX761042026-09-25
00190376668307CONTOUR3DAIX760002026-09-25
00190376733470CONTOUR3DC3DRODA2026-09-25
00190376778372InvictusVMRIN2026-08-19
00190376778396InvictusVMTIN2026-08-19
00190376768847Invictus171442026-08-17
00190376544397Invictus17920-012026-07-30
00190376544403Invictus17920-022026-07-30
00190376544410Invictus17920-032026-07-30
00190376544427Invictus17920-042026-07-30
00190376544434Invictus17920-052026-07-30
00190376544441Invictus17920-062026-07-30
00190376544458Invictus17920-072026-07-30
00190376544465Invictus17920-082026-07-30
00190376544472Invictus17920-092026-07-30
00190376544489Invictus17920-102026-07-30
00190376544496Invictus179212026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G247CPMX10CPMX1Compremium AGLXC2025-05-19
07540162030093MY01 Mobile ApplicationMY01 IncLXC2025-04-29
10840199544223Rhoton Spetzler Type SetKOROS U.S.A., INC.LXC2022-12-31
10810063754652Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754669Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754676Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754683Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754690Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754706Safco Nitrilex UltraSoft GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754713Safco Nitrilex UltraSoft GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754720Safco Nitrilex UltraSoft GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754737Safco Nitrilex UltraSoft GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754744Safco Nitrilex UltraSoft GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754751Safco Nitrilex GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754768Safco Nitrilex GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754775Safco Nitrilex GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754782Safco Nitrilex GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754799Safco Nitrilex GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754812Safco Nitrilex Prevail GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754829Safco Nitrilex Prevail GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754843Safco Nitrilex Prevail GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754655Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754662Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754686Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754693Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754709Safco Nitrilex UltraSoft GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754747Safco Nitrilex UltraSoft GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754761Safco Nitrilex GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754778Safco Nitrilex GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
D72310279053Safco Universal X-Ray Film MountsSAFCO DENTAL SUPPLY CO.LXC2022-11-22