FDA.reportPublic FDA data

PEEK IntraLine

Primary DI
07613154644599
Brand
PEEK IntraLine
Company
STRYKER CORPORATION
Model
3910-400-025
Catalog number
3910-400-025
Device description
PEEK INTRALINE ANCHOR, 6.5MM WITH ¿ CIRCLE TAPER NEEDLES, 2 STRANDS #2 FORCE FIBER
Published
2015-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071157000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071157000STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORSStryker Endoscopy2007-09-17HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613154644599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613154644599076131546445997613154644599

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)624-4422xx@xx.xx

Regulatory Flags#

DUNS number
187502109
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327623338AXS LiftLIFT074095-01LIFT074095-012025-03-04
07613327623352AXS LiftLIFT074105-01LIFT074105-012025-03-04
07613327623376AXS LiftLIFT074110-01LIFT074110-012025-03-04
07613327623390AXS LiftLIFT074115-01LIFT074115-012025-03-04
07613327060027Precision Ideal Eyes05028190300502-819-0302016-09-23
07613327060072Precision Ideal Eyes05028230300502-823-0302016-09-23
07613327060102Precision Ideal Eyes05028231300502-823-1302016-09-23
07613327060119Precision Ideal Eyes05028270100502-827-0102016-09-23
07613327060126Precision Ideal Eyes05028230700502-823-0702016-09-23
07613327060140Precision Ideal Eyes05028270700502-827-0702016-09-23
07613327060157Precision Ideal Eyes05028271300502-827-1302016-09-23
07613327060164Precision Ideal Eyes05028270300502-827-0302016-09-23
07613327060232Precision Ideal Eyes05028230100502-823-0102016-09-23
07613327063875Precision Ideal Eyes, Speed-Lock05029270100502-927-0102016-09-23
07613327063882Precision Ideal Eyes, Speed-Lock05029270300502-927-0302016-09-23
07613327063899Precision Ideal Eyes, Speed-Lock05029270700502-927-0702016-09-23
07613327681741N/A48110005481100052025-09-03
07613327681727N/A48110004481100042025-09-03
07613327681758N/A48110006481100062025-09-03
37613327566162Neptune075020000007502000002024-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810112592832TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592849TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592986TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112592993TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
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00810112593099TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
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00810112593112TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593129TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
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