FDA.reportPublic FDA data

Anspach Helix™

Primary DI
00845384018148
Brand
Anspach Helix™
Company
Synthes GmbH
Model
L-2B-HX-G1
Catalog number
L-2B-HX-G1
Device description
ANSPACH HELIX™ 2 mm Fluted Ball, Extended Length
Published
2019-12-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
HBCMOTOR, DRILL, ELECTRIC
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2
HBCMotor, Drill, ElectricNeurology2
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183545000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183545000Anspach Helix Dissection ToolsThe Anspach Effort, Inc.2019-07-19HBE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845384018148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845384018148008453840181488453840181480845384018148

GMDN Terms#

Term, Definition table
TermDefinition
Cranial bur, single-useA rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal and/or diamond material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate soft or hard skull tissue. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500RA-DPYNA-anspachpowe@its.jnj.com

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810112599275TriLEAP04.900.251049002512025-03-20
00810112599169TriLEAP04.900.240049002402025-03-18
00810112599763TriLEAP03.900.407039004072025-03-18
00810112599176TriLEAP04.900.241049002412025-03-17
00810112599183TriLEAP04.900.242049002422025-03-17
00810112599190TriLEAP04.900.243049002432025-03-17
00810112599206TriLEAP04.900.244049002442025-03-17
00810112599213TriLEAP04.900.245049002452025-03-17
00810112599220TriLEAP04.900.246049002462025-03-17
00810112599237TriLEAP04.900.247049002472025-03-17
00810112599244TriLEAP04.900.248049002482025-03-17
00810112599251TriLEAP04.900.249049002492025-03-17
00810112599268TriLEAP04.900.250049002502025-03-17
00810112592467TriLeap Lower Etremity Anatomic Plating System60.900.307609003072024-02-23
00810112592528TriLeap Lower Extremity Anatomic Plating03.900.311039003112024-02-23
00810112592566TriLeap Lower Etremity Anatomic Plating System03.900.332039003322024-02-23
00810112597035TriLeap Lower Extremity Plating System04.900.057049000572024-02-21
00810112596793TriLEAP04.900.151049001512026-02-19
00810112597202TriLEAP04.913.035049130352026-02-19
00810112597219TriLEAP04.913.040049130402026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04589551366217P300-2A100NAKANISHI INC.ERL2026-06-26
04589551366217P300-2A100NAKANISHI INC.HBE2026-06-26
04589551366262P300-2A120NAKANISHI INC.ERL2026-06-26
04589551366262P300-2A120NAKANISHI INC.HBE2026-06-26
04589551366316P300-2S100NAKANISHI INC.HBE2026-06-26
04589551366316P300-2S100NAKANISHI INC.ERL2026-06-26
04589551366361P300-2S120NAKANISHI INC.ERL2026-06-26
04589551366361P300-2S120NAKANISHI INC.HBE2026-06-26
J021305020241Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-07-08
00821925033900DIEGOGyrus ACMI, LLCERL2024-07-25
00821925033917DIEGOGyrus ACMI, LLCERL2024-07-24
00821925034419DIEGOGyrus ACMI, LLCERL2024-07-23
07613327501292iBurSTRYKER CORPORATIONERL2021-08-12
07613327501308iBurSTRYKER CORPORATIONERL2021-08-12
07613327504019NASTRYKER CORPORATIONHBE2021-07-08
07613327504019NASTRYKER CORPORATIONERL2021-07-08
07613327504057NASTRYKER CORPORATIONERL2021-07-08
07613327504057NASTRYKER CORPORATIONHBE2021-07-08
00763000374730Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSERL2021-05-21
00763000374730Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBC2021-05-21
00763000374730Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2021-05-21
00643169912205Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBC2019-06-08
00643169912205Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2019-06-08
00643169912205Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSERL2019-06-08
10887587057026NASynthes GmbHHBE2019-02-22
10887587057026NASynthes GmbHERL2019-02-22
00821925011441DIEGOGyrus ACMI, LLCERL2017-05-11
00821925011410DIEGOGyrus ACMI, LLCERL2016-10-12
00821925028746DiegoGyrus ACMI, LLCERL2016-10-06
04546540517593ESSxSTRYKER CORPORATIONERL2016-09-24