FDA.report

A.L.P.S. mvX™

Primary DI
00196449015658
Brand
A.L.P.S. mvX™
Company
Tyber Medical LLC
Model
770709102
Catalog number
770709102
Device description
POSTERIOR FIBULA PLATE 10H 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
00196449015658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00196449015658001964490156581964490156580196449015658

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

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