FDA.reportPublic FDA data

PELVIC STABILIZER

Primary DI
00887868001406
Brand
PELVIC STABILIZER
Company
Biomet Orthopedics, LLC
Model
6081
Catalog number
6081
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JECCOMPONENT, TRACTION, INVASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JECComponent, Traction, InvasiveOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K933968000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K933968000ACE PELVIC STABILIZERAce Medical Co.1994-06-16JEC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868001406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868001406008878680014068878680014060887868001406

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, single-use, non-sterileAn assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868549236MULTI-DIRECTIONAL SCREW1312273081312273082022-11-14
00887868549243MULTI-DIRECTIONAL SCREW1312273091312273092022-11-14
00887868549250MULTI-DIRECTIONAL SCREW1312273101312273102022-11-14
00887868549267MULTI-DIRECTIONAL SCREW1312273111312273112022-11-14
00887868549274MULTI-DIRECTIONAL SCREW1312273121312273122022-11-14
00887868549281MULTI-DIRECTIONAL SCREW1312273131312273132022-11-14
00887868549298MULTI-DIRECTIONAL SCREW1312273141312273142022-11-14
00887868549304MULTI-DIRECTIONAL SCREW1312273151312273152022-11-14
00887868549311MULTI-DIRECTIONAL SCREW1312273161312273162022-11-14
00887868549328MULTI-DIRECTIONAL SCREW1312273181312273182022-11-14
00887868549335MULTI-DIRECTIONAL SCREW1312273201312273202022-11-14
00887868549342MULTI-DIRECTIONAL SCREW1312273221312273222022-11-14
00887868549359MULTI-DIRECTIONAL SCREW1312273241312273242022-11-14
00887868549366MULTI-DIRECTIONAL SCREW1312273261312273262022-11-14
00887868549373MULTI-DIRECTIONAL SCREW1312273281312273282022-11-14
00887868549380MULTI-DIRECTIONAL SCREW1312273301312273302022-11-14
00887868544699SMOOTH PEG1312270081312270082022-09-07
00887868544705SMOOTH PEG1312270091312270092022-09-07
00887868544712SMOOTH PEG1312270101312270102022-09-07
00887868544729SMOOTH PEG1312270111312270112022-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277681231MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681248MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681255MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681262MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681279MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681286MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681293MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681309MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681316MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681323MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681330MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681347MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681354MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277680463MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277680616MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277681026MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277681071MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277681392MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277680456MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680470MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680487MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680494MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680500MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680517MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680524MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680531MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680548MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680555MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680562MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680579MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29