FDA.reportPublic FDA data

ORTHOSORB LS1.3 mm STRAIGHT PIN KIT, 3 PINS

Primary DI
00887868130809
Brand
ORTHOSORB LS1.3 mm STRAIGHT PIN KIT, 3 PINS
Company
Biomet Orthopedics, LLC
Model
110010742
Catalog number
110010742
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVZPin, fixation, resorbable, hard tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVZPin, Fixation, Resorbable, Hard TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140625000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140625000ORTHOSORB LSBiomet, Inc.2014-04-18OVZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868130809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868130809008878681308098878681308090887868130809

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, bioabsorbableAn assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). It may also include instruments for the attachment of the implants such as screwdrivers or drills.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304474185Arcos® Modular Revision Hip System11-30210211-3021022015-10-24
00880304474246Arcos® Modular Revision Hip System11-30210111-3021012015-10-24
00880304539259Arcos® Modular Revision Hip System11-30210911-3021092015-10-24
00889024711280Jgrknt Reusable Fishmouth Perc GuideSSI008662SSI0086622026-08-25
00889024712034Percutaneous Soft Anchor Short 1.4mm GuideSSI008661SSI0086612026-08-25
00880304527386Active Articulation0100009900100009902020-05-15
00880304527393Active Articulation0100009910100009912020-05-15
00880304485020Active Articulation Hip SystemEP-200144EP-2001442015-11-03
00880304485037Active Articulation Hip SystemEP-200146EP-2001462015-11-03
00880304485044Active Articulation Hip SystemEP-200148EP-2001482015-10-24
00880304485051Active Articulation Hip SystemEP-200150EP-2001502015-10-24
00880304485068Active Articulation Hip SystemEP-200152EP-2001522015-10-24
00880304485075Active Articulation Hip SystemEP-200154EP-2001542015-10-24
00880304485082Active Articulation Hip SystemEP-200156EP-2001562015-10-24
00880304485099Active Articulation Hip SystemEP-200158EP-2001582015-10-24
00880304485105Active Articulation Hip SystemEP-200160EP-2001602015-10-24
00880304485112Active Articulation Hip SystemEP-200162EP-2001622015-10-24
00880304485129Active Articulation Hip SystemEP-200164EP-2001642015-11-04
00880304485136Active Articulation Hip SystemEP-200166EP-2001662015-10-24
00880304491328Active Articulation™ Dual Mobility Hip SystemXL-200144XL-2001442015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M209176060Guide Wire Subtalar 12BIOPRO, INC.OVZ2017-09-20
00887868130793ORTHOSORB LS1.3 mm STRAIGHT PIN KIT, 1PINBiomet Orthopedics, LLCOVZ2015-10-24
00887868130816ORTHOSORB LS2.0 mm STRAIGHT PIN KIT, 1 PINBiomet Orthopedics, LLCOVZ2015-10-24
00887868130823ORTHOSORB LS2.0 mm STRAIGHT PIN KIT, 3 PINSBiomet Orthopedics, LLCOVZ2015-10-24
00887868130830ORTHOSORB LS1.3mm TAPERED PIN KIT, 1 PINBiomet Orthopedics, LLCOVZ2015-10-24