DELTA

Primary DI
07613252727842
Brand
DELTA
Company
Stryker Leibinger GmbH & Co. KG
Model
70-92050
Catalog number
70-92050
Device description
DELTA 1.7MM STGRD-HOLE STRUT 116X14X0.5MM
Published
2015-09-24
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

Product Code Classifications#

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

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
07613252727842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613252727842076132527278427613252727842

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
Length116Millimeter
Width14Millimeter

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
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
07613252510932CRANIALMAP81-8103081-810302016-08-24
07613252510949CRANIALMAP81-8103181-810312016-08-24
07613327004250ORTHOMAP6007-616-0006007-616-0002017-12-12
07613327071955PROFESS81-8103381-810332016-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055662976649Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976656Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976663Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976670Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976687Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
03700569631840Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
03700569631857Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
00888118131867LEVEL ONE EXTREMITY, STERILEKLS-Martin L.P.HRS2026-04-23
00810112599268TriLEAPCROSSROADS EXTREMITY SYSTEMSHRS2025-03-17
00810112593341TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHRS2024-02-22
00885556838211Total Foot System 2Smith & Nephew, Inc.HRS2023-04-18
B562PKSMC0835NSLTIUS0Superior Mid-Shaft Narrow Straight Clavicle Plate Procedure Kit 8 hole, LeftWishbone Medical, Inc.HRS2019-09-06
B562PKSMC0835NSRTIUS0Superior Mid-Shaft Narrow Straight Clavicle Plate Procedure Kit 8 hole, RightWishbone Medical, Inc.HRS2019-09-06
00842188115424Radial Shortening PlateTrimed, INC.HRS2017-05-19
00842188115431Radial Shortening PlateTrimed, INC.HRS2017-05-19
00842188116636Locking PlatesTrimed, INC.HRS2017-05-19
00842188116643Locking PlatesTrimed, INC.HRS2017-05-19
00842188116650Locking PlatesTrimed, INC.HRS2017-05-19
00815432023592DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023608DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023615DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023622DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023639DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023646DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023653DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023660DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00842188114892Volar Fixed Angle PlatesTrimed, INC.HRS2017-02-13
00842188114908Volar Fixed Angle PlatesTrimed, INC.HRS2017-02-13
00842188100000Pin PlatesTrimed, INC.HRS2016-09-07
00842188100017Pin PlatesTrimed, INC.HRS2016-09-07