FDA.reportPublic FDA data

DELTA

Primary DI
07613327177534
Brand
DELTA
Company
Stryker Leibinger GmbH & Co. KG
Model
70-92059
Catalog number
70-92059
Device description
DELTA 1.7MM 3X21 HYBRID CNTRSINKS 0.5MM
Published
2018-04-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXRCOVER, BURR HOLE
HBWFASTENER, PLATE, CRANIOPLASTY
HRSPlate, fixation, bone
JEYPLATE, BONE
MAIFastener, fixation, biodegradable, soft tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXRCover, Burr HoleNeurology2
HBWFastener, Plate, CranioplastyNeurology2
HRSPlate, Fixation, BoneOrthopedic2
JEYPlate, BoneDental2
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113109000
K213777000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113109000STRYKER RESORBABLE FIXATION SYSTEMStryker2011-12-23HRS
K213777000Stryker Resorbable Fixation SystemStryker Leibinger Micro Implants2022-02-04JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327177534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327177534076133271775347613327177534

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, bioabsorbableA small, implantable sheet of firm material that is attached with screws to fractured craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is chemically degraded and typically absorbed by natural body processes (e.g., a degradable polymer). The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature049 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316153956
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
04546540678683NGENIUS6003-034-0006003-034-0002016-08-24
04546540391735NA6007-425-0006007-425-0002017-12-12
07613154481118NA81-8003781-800372016-08-24
07613327413229n/a8000-040-0018000-040-0012018-08-08
07613327631814RPS88008000008800-800-0002025-10-03
07613252196259FLUOROMAP81-8102281-810222025-01-28
07613252286622FLUOROMAP6006-600-3006006-600-3002025-01-28
07613327542202N/A81-8007081-800702023-05-11
07613327542370N/A81-8007181-800712023-05-11
07613327542998N/A81-8007281-800722023-05-11
04546540245038NA6000-005-0006000-005-0002016-08-24
04546540651563NGENIUS6000-014-0006000-014-0002016-08-24
04546540717450ORTHOMAP6003-672-0006003-672-0002016-08-24
07613252127444ORTHOMAP81-8004981-800492016-08-24
07613252355717ORTHOMAP81-8005081-800502016-08-24
07613252433538ORTHOMAP6003-672-3006003-672-3002016-08-24
07613252449089ORTHOMAP81-8005581-800552017-12-12
07613252449850ORTHOMAP81-8005681-800562017-12-12
07613252450108ORTHOMAP6007-616-1006007-616-1002017-12-12
07613252450115ORTHOMAP6007-616-3006007-616-3002017-12-12

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00888867627864Arthrex®ARTHREX, INC.MAI2026-10-07
05055662976649Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
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05055662976670Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976687Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
03700569631840Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
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00888118131867LEVEL ONE EXTREMITY, STERILEKLS-Martin L.P.HRS2026-04-23
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08809986482860CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482778CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-21
08809986482785CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-21
08809986482716CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482723CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482730CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482747CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482754CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
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