FDA.reportPublic FDA data

ORTHOSORB LS1.3mm TAPERED PIN KIT, 1 PIN

Primary DI
00887868130830
Brand
ORTHOSORB LS1.3mm TAPERED PIN KIT, 1 PIN
Company
Biomet Orthopedics, LLC
Model
110010745
Catalog number
110010745
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
00887868130830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868130830008878681308308878681308300887868130830

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
00887868561368VersaNail®2810-13-0372810130372023-09-07
00889024707061A.L.P.S.®2142-35-0072142350072026-05-11
00889024707078DRILL BIT2312002012312002012026-05-11
00889024707085DRILL BIT8290-29-0708290290702026-05-11
00880304410541FIBER OPTICS FOR RC RETRACTOR9085349085342019-06-11
00880304321946BIFURCATED FIBER OPTIC CABLE31-55550231-5555022017-07-28
008803044639124MM X 9FT. LIGHT CABLE9061179061172017-07-28
00889024707054CALIBRATED DRILL BIT2142-27-0702142270702026-04-27
00880304233102Biomet® Knee System1418721418722015-10-24
00880304233126Biomet® Knee System1418741418742015-10-24
00880304233140Biomet® Knee System1418761418762015-10-24
00880304233164Biomet® Knee System1418781418782015-10-24
00880304233171Biomet® Knee System1418801418802015-10-24
00880304233188Biomet® Knee System1418821418822015-10-24
00880304433403Vanguard® Knee System1841441841442015-10-24
00880304433410Vanguard® Knee System1841811841812015-10-24
00880304433564Vanguard® Knee System1842851842852015-10-24
00880304433984Vanguard® Knee System1842801842802015-10-24
00880304434356Vanguard® Knee System1842651842652015-10-24
00880304434363Vanguard® Knee System1842701842702015-10-24

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
00887868130809ORTHOSORB LS1.3 mm STRAIGHT PIN KIT, 3 PINSBiomet 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