FDA.reportPublic FDA data

Continuum

Primary DI
00850039803031
Brand
Continuum
Company
Pressio, Inc
Model
PS-01-2012A
Device description
ACDF IMPLANT KIT - 20X12MM ANGLED
Published
2023-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PHQAnterior Staple As Supplemental Fixation For Fusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHQAnterior Staple As Supplemental Fixation For FusionOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200301000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200301000UNiTi ACDF Implant SystemPressio, Inc.2021-02-03PHQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850039803031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850039803031008500398030318500398030310850039803031

GMDN Terms#

Term, Definition table
TermDefinition
Memory-alloy orthopaedic fixation plateA non-sterile implantable device made of a shape memory alloy (SMA) [e.g., nickel-titanium alloy (Nitinol)] designed for the fixation of a bone fracture without the use of screws or wires or other holding devices. It typically consists of a cylindrical or conical plate with a pair or pairs of gripping arms to bridge and stabilize the fracture gap of a bone, e.g., long bones, rib and sternum, and shield the site from stress as the bone heals. Compression is achieved by the temperature-controlled properties of the SMA. It is available in a variety of sizes and is typically surgically removed after the healing process. It is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8666484665INFO@PRESSIOSPINE.COM

Regulatory Flags#

DUNS number
084706556
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850039803000ContinuumPS-01-1412A2023-05-01
00850039803017ContinuumPS-01-1612A2023-05-01
00850039803024ContinuumPS-01-1812A2023-05-01
00850039803048ContinuumPS-01-1412S2023-05-01
00850039803055ContinuumPS-01-1612S2023-05-01
00850039803062ContinuumPS-01-1812S2023-05-01
00850039803079ContinuumPS-01-2012S2023-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850039803000ContinuumPressio, IncPHQ2023-05-01
00850039803017ContinuumPressio, IncPHQ2023-05-01
00850039803024ContinuumPressio, IncPHQ2023-05-01
00850039803048ContinuumPressio, IncPHQ2023-05-01
00850039803055ContinuumPressio, IncPHQ2023-05-01
00850039803062ContinuumPressio, IncPHQ2023-05-01
00850039803079ContinuumPressio, IncPHQ2023-05-01
03613720214007C-JAWSMEDICREA INTERNATIONALPHQ2017-02-02
03613720214014C-JAWSMEDICREA INTERNATIONALPHQ2017-02-02
03613720214106C-JAWSMEDICREA INTERNATIONALPHQ2017-02-02
03613720214151C-JAWSMEDICREA INTERNATIONALPHQ2017-02-02
03613720214168C-JAWSMEDICREA INTERNATIONALPHQ2017-02-02
03613720214281C-JAWSMEDICREA INTERNATIONALPHQ2017-02-02
03613720214298C-JAWSMEDICREA INTERNATIONALPHQ2017-02-02
03613720213994C-JAWSMEDICREA INTERNATIONALPHQ2017-02-02
03613720192206K-JAWSMEDICREA INTERNATIONALPHQ2015-10-23
03613720192213K-JAWSMEDICREA INTERNATIONALPHQ2015-10-23
03613720192220K-JAWSMEDICREA INTERNATIONALPHQ2015-10-23
03613720192237K-JAWSMEDICREA INTERNATIONALPHQ2015-10-23
03613720192244K-JAWSMEDICREA INTERNATIONALPHQ2015-10-23
03613720192251K-JAWSMEDICREA INTERNATIONALPHQ2015-10-23
03613720192268K-JAWSMEDICREA INTERNATIONALPHQ2015-10-23
03613720192275K-JAWSMEDICREA INTERNATIONALPHQ2015-10-23
03613720192282K-JAWSMEDICREA INTERNATIONALPHQ2015-10-23