FDA.reportPublic FDA data

ORTHOSORB LS1.3 mm STRAIGHT PIN KIT, 1PIN

Primary DI
00887868130793
Brand
ORTHOSORB LS1.3 mm STRAIGHT PIN KIT, 1PIN
Company
Biomet Orthopedics, LLC
Model
110010741
Catalog number
110010741
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
00887868130793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868130793008878681307938878681307930887868130793

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
00888480584162PRO OSTEON 2002B0402B0402015-10-24
00888480584179PRO OSTEON 2002B0452B0452015-10-24
00888480584186PRO OSTEON 2002B0752B0752015-10-24
00888480584247PRO OSTEON 2002G022G022015-10-24
00888480584254PRO OSTEON 2002G052G052015-10-24
00888480584339PRO OSTEON 200R2RG0052RG0052015-10-24
00888480584346PRO OSTEON 200R2RG022RG022015-10-24
00888480584353PRO OSTEON 200R2RG052RG052015-10-24
00888480584360PRO OSTEON 200R2RG152RG152015-10-24
00888480584476PRO OSTEON 5005B0405B0402015-10-24
00888480584483PRO OSTEON 5005B0755B0752015-10-24
00888480584490PRO OSTEON 5005B1005B1002015-10-24
00888480584575PRO OSTEON 5005G055G052015-10-24
00888480584582PRO OSTEON 5005G105G102015-10-24
00888480584599PRO OSTEON 5005G155G152015-10-24
00888480584629PRO OSTEON 5005G305G302015-10-24
00888480584681PRO OSTEON 500R5RB0105RB0102015-10-24
00888480584698PRO OSTEON 500R5RB0145RB0142015-10-24
00888480584704PRO OSTEON 500R5RB0245RB0242015-10-24
00888480584711PRO OSTEON 500R5RB0405RB0402015-10-24

Other Devices Sharing Product Codes#

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