FDA.reportPublic FDA data

Battalion

Primary DI
00190376006413
Brand
Battalion
Company
ALPHATEC SPINE, INC.
Model
27416-110-0300
Device description
BATTALION, LLIF PITUITARY RONGEUR, SERRATED, STRAIGHT, 3MM
Published
2020-06-17
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
HTXRONGEUR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190376006413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376006413001903760064131903760064130190376006413

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. 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
00190376541471ATEC Lateral Navigation Disc Prep Instruments267-01-000-10-N2024-12-18
00190376529158ATEC Posterior Navigation Disc Prep Instruments244-01-000-06-N2024-04-20
00190376529189ATEC Posterior Navigation Disc Prep Instruments244-01-000-12-N2024-04-20
00190376476162ATEC Lateral Navigation Disc Prep Instruments266-01-000-08-N2023-08-26
00190376476179ATEC Lateral Navigation Disc Prep Instruments266-01-000-10-N2023-08-26
00190376476186ATEC Lateral Navigation Disc Prep Instruments266-01-000-12-N2023-08-26
00190376522906ATEC Lateral Navigation Disc Prep Instruments266-01-000-14-N2023-08-26
00840180512395General InstrumentsCI-11129-34242026-05-15
00840180543214General InstrumentsCI-118992026-05-15
00840180543542General InstrumentsCI-11915-302026-05-15
00840180544785General InstrumentsCI-11939-080-R2026-05-15
00840180544914General InstrumentsCI-11939-080-L2026-05-15
00840180545324General InstrumentsCI-11968-06-S2026-05-15
00840180545331General InstrumentsCI-11968-06-L2026-05-15
00840180545362General InstrumentsCI-11968-S2026-05-15
00840180545416General InstrumentsCI-11972-012026-05-15
00840180545423General InstrumentsCI-11972-032026-05-15
00840180545430General InstrumentsCI-11972-022026-05-15
00840180545447General InstrumentsCI-11972-042026-05-15
00840180545461General InstrumentsCI-11969-L2026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD914341100Surgical DirectSurgical Direct, Inc.HTX2026-07-13
B382SD9227021010Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD92270212C0Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707140Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707150Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707160Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707170Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707180Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707190Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922734060Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922734070Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922734080Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922738100Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD9227381000Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD9227381010Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD9227381020Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922738990Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD92274510120Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD9227771090Surgical DirectSurgical Direct, Inc.HTX2026-07-10
00810168190396NAPACIFIC INSTRUMENTS, INC.HTX2026-06-26
00198506091216ELMED INCORPORATEDELMED INCORPORATEDHTX2026-06-03
00846338005719ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005726ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005757ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005764ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005771ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005788ForcepsELLIQUENCE, LLCHTX2026-06-02
00810189451490Surgical DesignSurgical Design, Inc.HTX2026-05-29
09348811172174INKAThe Trustee for KAISER FAMILY TRUSTHTX2025-11-21
08809695610370AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.HTX2025-03-17