FDA.report

A.L.P.S. mvX™

Primary DI
00196449015672
Brand
A.L.P.S. mvX™
Company
Tyber Medical LLC
Model
770709142
Catalog number
770709142
Device description
POSTERIOR FIBULA PLATE 14H RT
Published
2023-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HRSPlate, fixation, bone

Product Code Classifications

CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00196449015672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00196449015672001964490156721964490156720196449015672

GMDN Terms

TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)761-0933preese@tybermed.com
+1(866)761-0933ra@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 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 DIBrandCompanyProduct codePublished
00888118143266PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143273PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143280PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143297PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143303PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143310PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143327PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143334PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143341PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143358PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143365PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143372PURE PECTUSKLS-Martin L.P.HRS2026-03-23
10885862649690EquinoxeExactech, Inc.HRS2026-03-19
00841506141466Distal Elbow Plating SystemSKELETAL DYNAMICS L.L.C.HRS2026-03-05
05055662971552Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-03-04
05055662971569Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-03-04
08809986480521CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-03-04
00888867535053Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535077Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535091Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535114Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535138Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535152Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535176Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535190Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535213Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535237Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535251Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535275Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535299Arthrex®ARTHREX, INC.HRS2026-02-23