FDA.reportPublic FDA data

StelKast Generic Hip instruments

Primary DI
10840843112426
Brand
StelKast Generic Hip instruments
Company
Stelkast Incorporated
Model
SC3800-32
Device description
Drill, Bayonet, Aquila, 3.2mm X 32mm
Published
2019-04-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840843112426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084084311242610840843112426

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1(724)-941-6368customer_service@stelkast.com

Regulatory Flags#

DUNS number
804792265
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840843100157Provident Hip SystemSC1217-462015-03-03
10840843100164Provident Hip SystemSC1217-482015-04-15
10840843100171Provident Hip SystemSC1217-502015-04-15
10840843100188Provident Hip SystemSC1217-522015-04-15
10840843100195Provident Hip SystemSC1217-542015-04-15
10840843100201Provident Hip SystemSC1217-562015-04-15
10840843100218Provident Hip SystemSC1217-582015-04-15
10840843100225Provident Hip SystemSC1217-602015-04-15
10840843100232Provident Hip SystemSC1217-622015-04-15
10840843100249Provident Hip SystemSC1217-642015-04-15
10840843100256Provident Hip SystemSC1217-662015-04-15
10840843100263Provident Hip SystemSC1217-682015-04-15
10840843100270Provident Hip SystemSC1217-702015-04-15
10840843100287Provident Hip SystemSC1217-722015-04-15
10840843100805Zirconia Ceramic HeadSC1405-28mm +0M2015-10-07
10840843100812Zirconia Ceramic HeadSC1405-28mm +3.5 L2015-10-07
10840843100829Zirconia Ceramic HeadSC1405-28mm -3.5 S2015-10-07
10840843100836Zirconia Ceramic HeadSC1406-28mm +7 XL2015-10-07
10840843100843Proform Hip SystemSC1408-100-462015-02-17
10840843100850Proform Hip SystemSC1408-100-482015-02-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04048844358839MUTARS®implantcast GmbHHTW2026-03-24
00840314270245gSourceGSOURCE LLCHTW2026-03-20
00840314270252gSourceGSOURCE LLCHTW2026-03-20
00840314270269gSourceGSOURCE LLCHTW2026-03-20
00763000884543n/aMEDTRONIC SOFAMOR DANEK, INC.HTW2026-03-13
00888867500891Arthrex®ARTHREX, INC.HTW2026-03-13
00888867500921Arthrex®ARTHREX, INC.HTW2026-03-13
00817438028618N/AOmega Surgical Instruments IncHTW2026-03-03
06974940307007endophixSuzhou Endophix Co., Ltd.HTW2026-03-03
06974940307021endophixSuzhou Endophix Co., Ltd.HTW2026-03-03
06974940307038endophixSuzhou Endophix Co., Ltd.HTW2026-03-03
00889024706484Vanguard®Biomet Orthopedics, LLCHTW2026-02-27
00841435124929TecometTECOMET INC.HTW2026-02-26
08053782783731BRM TOOL VIP SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2026-02-19
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00810112598896TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTW2026-02-10
00199150062973Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTW2026-02-09
00889024683891G7® Revision Acetabular SystemZimmer, Inc.HTW2026-02-05
04026575282883General InstrumentWALDEMAR LINK GmbH & Co. KGHTW2026-02-02
04026575299188TrabecuLink Augments InstrumentsWALDEMAR LINK GmbH & Co. KGHTW2026-02-02
04026575414932General InstrumentWALDEMAR LINK GmbH & Co. KGHTW2026-02-02
04026575427130General InstrumentWALDEMAR LINK GmbH & Co. KGHTW2026-02-02
00810056993122corraCarlsmed, Inc.HTW2026-01-30
00810056993153corraCarlsmed, Inc.HTW2026-01-30
00810056993160corraCarlsmed, Inc.HTW2026-01-30