FDA.reportPublic FDA data

StabilizOrtho

Primary DI
B650QZPSHMEDBX0
Brand
StabilizOrtho
Company
Stabiliz Orthopaedics, Inc.
Model
QZPSHMEDBX
Device description
QuikZip Wound Closure Device - QuikZip Pack - Short Pads, Medium Straps
Published
2026-10-23
Public version status
New
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
MKYSystem, Skin Closure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKYSystem, Skin ClosureGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B650QZPSHMEDBX0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Skin-closing tension deviceA sterile device designed to apply continuous tension to an area of skin to stretch it to achieve a surplus of full thickness skin and subcutaneous tissue for the closure of a wound where the margins are too far apart for suturing, or prior to the surgical excision of a skin defect, or for the implantation of a prosthesis to provide additional skin for coverage; it may additionally be used for offloading sutures in closed wounds. It is typically available as automatic self-closing skin hooks, or a tension line inserted through skin hooks at the wound margins for constant or adjustable tension application. It may be used as an alternative to skin grafting. This is a single-use device.

Regulatory Flags#

DUNS number
832740091
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
false
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
B650SCS370450StabilizOrthoSCS370452024-10-31
B650SCS370500StabilizOrthoSCS370502024-10-31
B650SCS370550StabilizOrthoSCS370552024-10-31
B650SCS370600StabilizOrthoSCS370602024-10-31
B650SCS370650StabilizOrthoSCS370652024-10-31
B650SCS370700StabilizOrthoSCS370702024-10-31
B650SCS370750StabilizOrthoSCS370752024-10-31
B650SCS370800StabilizOrthoSCS370802024-10-31
B650SCS370850StabilizOrthoSCS370852024-10-31
B650SCS370900StabilizOrthoSCS370902024-10-31
B650SFX830700StabilizOrthoSFX830702024-10-31
B650SFX830750StabilizOrthoSFX830752024-10-31
B650SFX830800StabilizOrthoSFX830802024-10-31
B650SFX830850StabilizOrthoSFX830852024-10-31
B650SFX830900StabilizOrthoSFX830902024-10-31
B650SFX830950StabilizOrthoSFX830952024-10-31
B650SFX831000StabilizOrthoSFX831002024-10-31
B650SFX831050StabilizOrthoSFX831052024-10-31
B650SFX831100StabilizOrthoSFX831102024-10-31
B650SFX831150StabilizOrthoSFX831152024-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860007834257SUTUREGARD® InterlockSUTUREGARD MEDICAL, INCMKY2026-01-09
10860007834254SUTUREGARD® InterlockSUTUREGARD MEDICAL, INCMKY2026-01-09
06972864363024sknjxNingbo Chinmed Technology Co., Ltd.MKY2025-11-20
00844735006728DERMACLOSESYNOVIS MICRO COMPANIES ALLIANCE, INCMKY2024-06-27
00844735006735DERMACLOSESYNOVIS MICRO COMPANIES ALLIANCE, INCMKY2024-06-27
07540161750015AbCloInventorr MD IncMKY2023-12-04
00840118605175ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611435ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611459ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611473ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611497ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611510ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611534ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611558ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118613644ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118605182ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611442ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611466ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611480ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611503ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611527ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611541ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611565ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118613651ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
08800125000020DIALFIX 11DFIXMKY2023-01-28
08800125000037DIALFIX 15DFIXMKY2023-01-28
08800125000044DIALFIX 18DFIXMKY2023-01-28
08800125000051DIALFIX 21DFIXMKY2023-01-28
08800125000068DIALFIX 24DFIXMKY2023-01-28
08800125000075DIALFIX PLUS 3DFIXMKY2023-01-28