FDA.reportPublic FDA data

PANGEA

Primary DI
07613327539677
Brand
PANGEA
Company
Stryker GmbH
Model
706451
Catalog number
706451
Device description
Frame Fixator, MIS
Published
2023-06-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone
HWCScrew, fixation, bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222381000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222381000PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH2023-04-27HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327539677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327539677076133275396777613327539677

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length345Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
Device count
1
HCT/P
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886385017365STAR908-0110-02908-0110-022022-02-14
00886385018836STAR933-0003-02933-0003-022022-02-14
00886385018843STAR933-0003-03933-0003-032022-02-14
00886385019055STAR933-0025-02933-0025-022022-02-14
00886385019062STAR933-0025-03933-0025-032022-02-14
00886385019147STAR933-0029-02933-0029-022022-02-14
00886385017150STAR905-0066905-00662020-09-24
07613327350296NA2351-00202351-00202018-11-02
07613327361650NA2351-01402351-01402018-11-02
07613327361667NA2351-03402351-03402018-11-02
07613327361674NA2351-00302351-00302018-11-02
07613327361681NA2351-00602351-00602018-11-02
07613327361780NA2351-42902351-42902018-11-02
07613327368154NA2351-00702351-00702018-11-02
07613327368178NA2351-42802351-42802018-11-02
07613327376197NA2351-04202351-04202018-11-01
07613327376203NA2351-03802351-03802018-11-01
00886385016412STAR™400-2502017-06-27
00886385016429STAR™400-2512017-06-27
00886385016436STAR™400-2522017-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986482594CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-23
00810112599275TriLEAPSynthes GmbHHRS2025-03-20
00810112599275TriLEAPSynthes GmbHHWC2025-03-20
00810112599169TriLEAPSynthes GmbHHWC2025-03-18
00810112599169TriLEAPSynthes GmbHHRS2025-03-18
00810112599176TriLEAPSynthes GmbHHWC2025-03-17
00810112599176TriLEAPSynthes GmbHHRS2025-03-17
00810112599183TriLEAPSynthes GmbHHWC2025-03-17
00810112599183TriLEAPSynthes GmbHHRS2025-03-17
00810112599190TriLEAPSynthes GmbHHWC2025-03-17
00810112599190TriLEAPSynthes GmbHHRS2025-03-17
00810112599206TriLEAPSynthes GmbHHWC2025-03-17
00810112599206TriLEAPSynthes GmbHHRS2025-03-17
00810112599213TriLEAPSynthes GmbHHRS2025-03-17
00810112599213TriLEAPSynthes GmbHHWC2025-03-17
00810112599220TriLEAPSynthes GmbHHWC2025-03-17
00810112599220TriLEAPSynthes GmbHHRS2025-03-17
00810112599237TriLEAPSynthes GmbHHWC2025-03-17
00810112599237TriLEAPSynthes GmbHHRS2025-03-17
00810112599244TriLEAPSynthes GmbHHWC2025-03-17
00810112599244TriLEAPSynthes GmbHHRS2025-03-17
00810112599251TriLEAPSynthes GmbHHWC2025-03-17
00810112599251TriLEAPSynthes GmbHHRS2025-03-17
00810112599268TriLEAPSynthes GmbHHWC2025-03-17
00810112599268TriLEAPSynthes GmbHHRS2025-03-17
00810112592245TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592245TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592252TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592252TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592429TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23