FDA.reportPublic FDA data

DELTA

Primary DI
34546540337406
Brand
DELTA
Company
Stryker Leibinger GmbH & Co. KG
Model
70-17206
Catalog number
70-17206
Device description
DELTA 1.7X6MM SCREW, 2 EA
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
JEYPLATE, BONE
MAIFASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213777000
K993061000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
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
34546540337406PrimaryGS10
04546540337405Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3454654033740634546540337406
04546540337405045465403374054546540337405

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone screw, bioabsorbableA small, sterile, threaded rod with a slotted head used for craniofacial bone (including the maxilla and/or mandible) fracture fixation by being screwed into bone to hold plates to bone or to provide direct interfragmentary stabilization of bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). The device may be self-drilling/self-tapping. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, and craniotomy flap fixation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length6Millimeter

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
2
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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00888118154620LEVEL ONE CMFKLS-Martin L.P.JEY2026-07-21
00888118154637LEVEL ONE CMFKLS-Martin L.P.JEY2026-07-21
07613327694482DELTAStryker Leibinger GmbH & Co. KGGXR2026-07-21