FDA.reportPublic FDA data

A.L.P.S. mvX™

Primary DI
00196449012916
Brand
A.L.P.S. mvX™
Company
Tyber Medical LLC
Model
770002181
Catalog number
770002181
Device description
1.8MM DRILL MID
Published
2023-12-15
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
true

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
00196449012916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196449012916001964490129161964490129160196449012916

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, single-useA metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)761-0933preese@tybermed.com

Regulatory Flags#

DUNS number
010968002
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00196449024803Cannulated Headless Screw - Full Thread04.345.008TS2025-07-19
00196449024834Cannulated Headless Screw - Full Thread04.345.009TS2025-07-19
00196449024865Cannulated Headless Screw - Full Thread04.345.010TS2025-07-19
00196449024896Cannulated Headless Screw - Full Thread04.345.011TS2025-07-19
00196449024926Cannulated Headless Screw - Full Thread04.345.012TS2025-07-19
00196449024957Cannulated Headless Screw - Full Thread04.345.013TS2025-07-19
00196449024988Cannulated Headless Screw - Full Thread04.345.014TS2025-07-19
00196449025015Cannulated Headless Screw - Full Thread04.345.015TS2025-07-19
00196449025046Cannulated Headless Screw - Full Thread04.345.016TS2025-07-19
00196449025077Cannulated Headless Screw - Full Thread04.345.017TS2025-07-19
00196449025107Cannulated Headless Screw - Full Thread04.345.018TS2025-07-19
00196449025138Cannulated Headless Screw - Full Thread04.345.019TS2025-07-19
00196449025169Cannulated Headless Screw - Full Thread04.345.020TS2025-07-19
00196449025190Cannulated Headless Screw - Full Thread04.345.022TS2025-07-19
00196449025220Cannulated Headless Screw - Full Thread04.345.024TS2025-07-19
00196449025251Cannulated Headless Screw - Full Thread04.345.026TS2025-07-19
00196449025282Cannulated Headless Screw - Full Thread04.345.028TS2025-07-19
00196449025312Cannulated Headless Screw - Full Thread04.345.030TS2025-07-19
00196449025343Cannulated Headless Screw - Full Thread04.345.032TS2025-07-19
00196449025374Cannulated Headless Screw - Full Thread04.345.034TS2025-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810168190457NAPACIFIC INSTRUMENTS, INC.HTW2026-05-26
04048844358617MUTARS®implantcast GmbHHTW2026-03-24
04048844358716MUTARS®implantcast GmbHHTW2026-03-24
04048844358792MUTARS®implantcast GmbHHTW2026-03-24
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
00190376709253AMP IIALPHATEC SPINE, INC.HTW2026-02-18
00810112597455TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTW2026-02-10
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