FDA.report

Battalion

Primary DI
00840967129648
Brand
Battalion
Company
ALPHATEC SPINE, INC.
Model
27440-150
Device description
BATTALION, LLIF RIGHT BLADE, 150mm
Published
2020-06-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GADRETRACTOR

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840967129648PrimaryGS10

GMDN Terms

TermDefinition
Surgical retraction system, reusableA frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
true
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 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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00198506089763ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00198506089770ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00198506089787ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00841536148008ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-24
00190776418342MillenniumAvalign Technologies, Inc.GAD2026-03-23
00190776418359MillenniumAvalign Technologies, Inc.GAD2026-03-23
00198506089695ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-20
00199150062263Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-03-20
00199150062270Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-03-20
00199150062287Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-03-20
00840277133427Innomed, Inc.INNOMED, INC.GAD2026-03-20
00198506055393ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-19
10885862648587EquinoxeExactech, Inc.GAD2026-03-19
10885862648594EquinoxeExactech, Inc.GAD2026-03-19
10885862661234N/AExactech, Inc.GAD2026-03-19
10885862661371NovationExactech, Inc.GAD2026-03-19
10885862661388NovationExactech, Inc.GAD2026-03-19
10885862661395NovationExactech, Inc.GAD2026-03-19
10885862661401NovationExactech, Inc.GAD2026-03-19
00198506089671ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-17
00198506089688ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-17
00810123209996Adler Instrument CompanyAdler, Inc.GAD2026-03-17
00810220800027Adler Instrument CompanyAdler, Inc.GAD2026-03-17
20763000284897OctoBase™MEDTRONIC, INC.GAD2026-03-14
00841536147766ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-13
00841536147773ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-13
00841536147780ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-13
00810158219298PRINCETONPrinceton Medical Group, Inc.GAD2026-03-12
00810158219342PRINCETONPrinceton Medical Group, Inc.GAD2026-03-12
M93074301120S0Life InstrumentsLife Instrument CorporationGAD2026-03-12