FDA.reportPublic FDA data

VariAx

Primary DI
04546540578747
Brand
VariAx
Company
Stryker Trauma SA
Model
54-25387S
Catalog number
54-25387S
Device description
VOLAR SMARTLOCK DR PLATE,STAND.RT,LONG
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPLATE, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540578747PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540578747045465405787474546540578747

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterileA sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
481999654
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
07613327667738NASIT0006000SIT00060002025-03-28
07613327084191STEINMANN3593-1-0903593-1-0902025-01-09
07613327614633PANGEA5420045420042024-12-01
07613327624786PANGEA542110S542110S2024-12-01
07613327624809PANGEA5421125421122024-12-01
07613327624816PANGEA5421375421372024-12-01
07613327624830PANGEA5421855421852024-12-01
07613327624847PANGEA5421385421382024-12-01
07613327624861PANGEA5421185421182024-12-01
07613327624878PANGEA5421365421362024-12-01
07613327624885PANGEA5421195421192024-12-01
07613327624908PANGEA5421325421322024-12-01
07613327624915PANGEA542130S542130S2024-12-01
07613327624939PANGEA5421395421392024-12-01
07613327624977PANGEA5421725421722024-12-01
07613327624984PANGEA5421545421542024-12-01
07613327624991PANGEA5421205421202024-12-01
07613327625011PANGEA542132S542132S2024-12-01
07613327625028PANGEA5421135421132024-12-01
07613327625035PANGEA5421865421862024-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118145284PURE PECTUSKLS-Martin L.P.HRS2026-05-25
00888118145291PURE PECTUSKLS-Martin L.P.HRS2026-05-25
07640187463392POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, LeftBonebridge AGHRS2026-05-22
07640187463408POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, RightBonebridge AGHRS2026-05-22
07640187463415POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, LeftBonebridge AGHRS2026-05-22
07640187463422POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, RightBonebridge AGHRS2026-05-22
07640187463439POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, LeftBonebridge AGHRS2026-05-22
07640187463446POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, RightBonebridge AGHRS2026-05-22
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