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
07613327605716PANGEA5422525422522026-06-02
07613327648331PANGEA5421605421602026-06-02
07613327648355PANGEA7039197039192026-06-02
07613327648362PANGEA5421615421612026-06-02
07613327648379PANGEA7039187039182026-06-02
37613153159729PROFYLE59-1204959-120492015-09-24
37613153159736PROFYLE59-1704959-170492015-06-24
37613153159743PROFYLE59-2304959-230492015-07-03
07613154583829PROFYLE59-12049E59-12049E2015-06-24
07613154583836PROFYLE59-17049E59-17049E2015-06-24
07613154583843PROFYLE59-23049E59-23049E2015-07-03
07613327625066PANGEA5421165421162024-12-01
00886385019741SR PIP17-13152017-06-27
00886385019758SR PIP17-13162017-06-27
00886385019765SR PIP17-13172017-06-27
00886385019772SR PIP17-13182017-06-27
00886385019789SR PIP17-13192017-06-27
00886385019796SR PIP17-13202017-06-27
00886385019802SR PIP17-13212017-06-27
00886385019819SR PIP17-13222017-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008405368000393P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000463P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000533P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000603P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
08809986479938CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
08809986479945CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
10850070500125CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500132CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500149CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500156CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500163CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500170CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500187CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500194CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500200CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500217CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500224CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500231CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500248CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500255CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500262CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500279CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500286CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500293CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500309CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500316CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500323CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500330CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500347CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500354CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22