FDA.reportPublic FDA data

NA

Primary DI
10705034000046
Brand
NA
Company
DEPUY SPINE, LLC
Model
1374
Catalog number
1374
Device description
ACE HALO VEST SYSTEM UNIVERSAL TONG KIT
Published
2016-06-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAXTONG, SKULL FOR TRACTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAXTong, Skull For TractionNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K954069000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954069000ACE CERVICAL TRACTION HALOZS, TONGS & PINSAce Medical Co.1995-10-12HAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034000046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503400004610705034000046

GMDN Terms#

Term, Definition table
TermDefinition
Surgical traction skull tongsAn instrument used during orthopaedic surgery to perform traction on the cervical spine by applying an upward force to the skull that causes hyperextension of the head and neck. It is typically a two-arm pivoted instrument that is attached to the skull using pins (either partially implanted or not); the proximal end includes a mechanism (e.g., an adjustable threaded bolt and nut) responsible for the application of the traction force. This device is typically used during procedures to treat a fractured spine. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
107105876
Device count
1
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034471716N/A6983411716983411712022-10-07
10705034570105N\A6983447336983447332022-10-07
10705034570211N/A6983447246983447242022-10-07
10705034570228N\A6983447346983447342022-10-07
10705034570433N/A6983447266983447262022-10-07
10705034570501N\A6983447326983447322022-10-07
10705034570624N/A6983447286983447282022-10-07
10705034570693N\A6983447316983447312022-10-07
10705034570723N/A6983447276983447272022-10-07
10705034458267N/A6983393806983393802022-02-02
10705034137049BENGAL1873011131873011132015-09-24
10705034137056BENGAL1873011141873011142015-09-24
10705034137063BENGAL1873011151873011152015-09-24
10705034137070BENGAL1873011161873011162015-09-24
10705034585321TRIALTIS Spine System5560-12-4560FS5560124560FS2026-05-18
10705034585796TRIALTIS Spine System5560-12-4560S5560124560S2026-05-18
10705034604466TRIALTIS Spine System5560-12-7025CS5560127025CS2026-05-18
10705034359007SPOTLIGHT2829509002829509002016-06-30
10705034217727PIPELINE2871050612871050612019-06-06
10705034217789PIPELINE2871050852871050852019-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00650551003861HALO TRAUMA KITPMT CORPORATIONHAX2025-03-10
00650551004417HALO TRAUMA KITPMT CORPORATIONHAX2025-03-10
00650551004424HALO RINGPMT CORPORATIONHAX2025-03-10
00650551004790HALO RINGPMT CORPORATIONHAX2025-03-10
00650551042006HALO RINGPMT CORPORATIONHAX2025-03-10
00650551042556HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042563HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042570HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042587HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042594HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042600HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042617HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042624HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042631HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042648HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042655HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042792HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042808HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042815HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042822HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042839HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042846HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042853HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042860HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042877HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042884HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551042891HALO VEST LINERPMT CORPORATIONHAX2025-03-10
00650551045052HALO RINGPMT CORPORATIONHAX2025-03-10
00650551045069HALO RINGPMT CORPORATIONHAX2025-03-10
00650551093923HALO SYSTEM COMPONENTPMT CORPORATIONHAX2025-03-10