FDA.reportPublic FDA data

DELTA

Primary DI
07613327423648
Brand
DELTA
Company
Stryker Leibinger GmbH & Co. KG
Model
70-92071
Catalog number
70-92071
Device description
DELTA 1.7MM STARFISH 17MM CNTRSNK 0.5MM
Published
2018-05-22
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
K993061000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113109000STRYKER RESORBABLE FIXATION SYSTEMStryker2011-12-23HRS
K213777000Stryker Resorbable Fixation SystemStryker Leibinger Micro Implants2022-02-04JEY
K993061000STRYKER LEIBINGER RESORBABLE FIXATION SYSTEMStryker Instruments1999-11-19MAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327423648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327423648076133274236487613327423648

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
07613252286578FLUOROMAP6006-600-0006006-600-0002025-01-28
07613327542202N/A81-8007081-800702023-05-11
07613327542219N/A6003-700-3006003-700-3002023-05-11
07613327542363N/A6003-710-3006003-710-3002023-05-11
07613327542370N/A81-8007181-800712023-05-11
07613327542875N/A6007-700-3006007-700-3002023-05-11
07613327542998N/A81-8007281-800722023-05-11
04546540505712NA6004-650-0006004-650-0002016-08-24
04546540651600ORTHOMAP6005-660-0006005-660-0002016-08-24
04546540651624ORTHOMAP6005-661-0006005-661-0002016-08-24
07613154637164NA6004-650-3006004-650-3002016-08-24
07613252127413ORTHOMAP6005-660-3006005-660-3002016-08-24
07613252355717ORTHOMAP81-8005081-800502016-08-24
07613252433521ORTHOMAP6003-672-1006003-672-1002016-08-24
07613252433538ORTHOMAP6003-672-3006003-672-3002016-08-24
07613252448761ORTHOMAP6003-655-3006003-655-3002017-12-12
07613252448778ORTHOMAP6003-655-1006003-655-1002017-12-12
07613252449089ORTHOMAP81-8005581-800552017-12-12
04546540678683NGENIUS6003-034-0006003-034-0002016-08-24
04546540391735NA6007-425-0006007-425-0002017-12-12

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