FDA.reportPublic FDA data

Delta

Primary DI
07613327123364
Brand
Delta
Company
Stryker Leibinger GmbH & Co. KG
Model
70-92055
Catalog number
70-92055
Device description
DELTA 1.7MM PANEL 1X21 CTRSINKS X 0.5MM
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
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
07613327123364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327123364076133271233647613327123364

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, bioabsorbableA small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, and/or cover a burr hole. It is made of bioabsorbable materials (e.g., degradable polymer) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or bioabsorbable plate fixation implants (i.e., bone screws), may be included with the plate.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
316153956
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04546540256805NA62-0053462-005342016-10-19
04546540356628NA62-0030262-003022016-12-08
04546540366788NA62-2052062-205202016-10-19
04546540391391NA62-0020862-002082016-12-08
07613154185443NA62-0044162-004412016-12-08
07613154731800NA92-1592392-159232017-01-11
07613154732685NA92-1592192-159212017-01-11
07613252313069DELTA70-9200970-920092015-09-24
07613252444220DELTA70-9200670-920062015-09-24
07613252444244DELTA70-9200370-920032015-09-24
07613252727002DELTA70-9204770-920472015-09-24
07613327090123NA62-2014962-201492016-10-19
07613327090192NA62-2013962-201392016-10-19
07613327123340Delta70-9205670-920562015-09-24
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

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