FDA.report

DELTA

Primary DI
07613327594591
Brand
DELTA
Company
Stryker Leibinger GmbH & Co. KG
Model
77-22605
Catalog number
77-22605
Device description
Delta low profile emerg. screw 5 PK
Published
2023-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HBWFASTENER, PLATE, CRANIOPLASTY

Product Code Classifications

CodeDeviceSpecialtyClass
HBWFastener, Plate, CranioplastyNeurology2

Premarket Submissions

SubmissionSupplement
K230733000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K230733000Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG2023-08-05JEY

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
37613327594592PrimaryGS10
07613327594591Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3761332759459237613327594592
07613327594591076133275945917613327594591

GMDN Terms

TermDefinition
Craniofacial bone screw, bioabsorbableA small, threaded rod intended to be implanted (screwed) in craniofacial bone (including the maxilla and/or mandible) for fixation of fractures (to hold plates to bone or to provide direct interfragmentary stabilization of bone), transplanted bone chips/grafts, and/or dental regeneration membranes; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers/metals). The device may be self-drilling/self-tapping. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, and/or oral regenerative treatments.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length6Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature049 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
316153956
Device count
5
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

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07613327682724NA92-0232492-023242026-02-27
37613327090810NA92-1710592-171052015-09-24
37613327090827NA92-1710492-171042015-09-24
37613327090834NA92-1710692-171062015-09-24
37613327090841NA92-1710892-171082015-09-24
37613327090858NA92-8170392-817032015-09-24
37613327090865NA92-8170492-817042015-09-24
37613327090872NA92-8170592-817052015-09-24
37613327090889NA92-8170692-817062015-09-24
37613327090902NA92-8170892-817082015-09-24
37613327090919NA92-8171092-817102015-09-24
37613327090926NA92-8171292-817122015-09-24
37613327090940NA92-8190592-819052015-09-24
07613327579840N/A7000015775847000015775842025-09-08
07613327680522NA92-5553192-555312025-07-31
07613327651461NA92-0551292-055122025-07-09
07613327504385NA92-0233392-023332020-05-12
07613327504392NA92-0233292-023322020-05-12
07613327353563NA6002-140-2006002-140-2002025-02-19

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