FDA.reportPublic FDA data

IXOS

Primary DI
00850005146056
Brand
IXOS
Company
HNM STUCKENBROCK, INC.
Model
HS-26-905-13-09
Catalog number
HS-26-905-13-09
Device description
smartDrive ø2.5mm LOCKING SCREW (L)13mm, TI
Published
2019-07-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171624000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171624000IXOS Radius Plate SystemStuckenbrock Medizintechnik GmbH2018-03-29HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005146056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005146056008500051460568500051460560850005146056

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
117068079
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005146759HBS2HS-26-800-11-09HS-26-800-11-092020-12-25
00850005146766HBS2HS-26-800-12-09HS-26-800-12-092020-12-25
00850005146773HBS2HS-26-800-13-09HS-26-800-13-092020-12-25
00850005146780HBS2HS-26-800-14-09HS-26-800-14-092020-12-25
00850005146797HBS2HS-26-800-15-09HS-26-800-15-092020-12-25
00850005146803HBS2HS-26-800-16-09HS-26-800-16-092020-12-25
00850005146810HBS2HS-26-800-17-09HS-26-800-17-092020-12-25
00850005146827HBS2HS-26-800-18-09HS-26-800-18-092020-12-25
00850005146834HBS2HS-26-800-19-09HS-26-800-19-092020-12-25
00850005146841HBS2HS-26-800-20-09HS-26-800-20-092020-12-25
00850005146858HBS2HS-26-800-21-09HS-26-800-21-092020-12-25
00850005146865HBS2HS-26-800-22-09HS-26-800-22-092020-12-25
00850005146872HBS2HS-26-800-23-09HS-26-800-23-092020-12-25
00850005146889HBS2HS-26-800-24-09HS-26-800-24-092020-12-25
00850005146896HBS2HS-26-800-25-09HS-26-800-25-092020-12-25
00850005146902HBS2HS-26-800-26-09HS-26-800-26-092020-12-25
00850005146919HBS2HS-26-800-27-09HS-26-800-27-092020-12-25
00850005146926HBS2HS-26-800-28-09HS-26-800-28-092020-12-25
00850005146933HBS2HS-26-800-29-09HS-26-800-29-092020-12-25
00850005146940HBS2HS-26-800-30-09HS-26-800-30-092020-12-25

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