FDA.reportPublic FDA data

NA

Primary DI
00889024172203
Brand
NA
Company
Zimmer, Inc.
Model
6500-07-048
Catalog number
6500-07-048
Published
2015-10-09
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
HRSPLATE, FIXATION, BONE
HWCScrew, fixation, bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K850770000
K892228000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K850770000INTERMEDICS BONE SCREWIntermedics Orthopedics1985-04-19HWC
K892228000INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEMIntermedics Orthopedics1989-10-06HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024172203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024172203008890241722038890241722030889024172203

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length48Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmer.com
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024710580Custom Femoral Lateralizing ReamerSSI008673SSI0086732026-07-20
00889024711495Z1 ExtractorSSI008663SSI0086632026-07-20
00889024701281Identity® Shoulder System11007733110077332026-06-10
00889024701298Identity® Shoulder System11007734110077342026-06-10
00889024701304Identity® Shoulder System11007735110077352026-06-10
00889024701311Identity® Shoulder System11007736110077362026-06-10
00889024701328Identity® Shoulder System11007737110077372026-06-10
00889024701335Identity® Shoulder System11007738110077382026-06-10
00889024701342Identity® Shoulder System11007739110077392026-06-10
00889024701359Identity® Shoulder System11007740110077402026-06-10
00889024701366Identity® Shoulder System11007741110077412026-06-10
00889024701373Identity® Shoulder System11007742110077422026-06-10
00889024701380Identity® Shoulder System11007743110077432026-06-10
00889024701397Identity® Shoulder System11007744110077442026-06-10
00889024701403Identity® Shoulder System11007745110077452026-06-10
00889024701410Identity® Shoulder System11007746110077462026-06-10
00889024701427Identity® Shoulder System11007747110077472026-06-10
00889024701434Identity® Shoulder System11007748110077482026-06-10
00889024701441Identity® Shoulder System11007749110077492026-06-10
00889024701458Identity® Shoulder System11007750110077502026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196449033393A.L.P.S. mvX™Tyber Medical, LLCHWC2026-07-23
00196449033409A.L.P.S. mvX™Tyber Medical, LLCHWC2026-07-23
00888233028875Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233028882Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233028899Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086110Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086127Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086134Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086141Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086158Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086165Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086172Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086189Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086196Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086202Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086219Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00841731140395ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140401ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140418ARTEMIS FUZEVILEX LLCHWC2026-07-22
00196449011735A.L.P.S. mvX™Tyber Medical, LLCHWC2024-01-20
00196449011742A.L.P.S. mvX™Tyber Medical, LLCHWC2024-01-20
00196449011759A.L.P.S. mvX™Tyber Medical, LLCHWC2024-01-20
00196449011766A.L.P.S. mvX™Tyber Medical, LLCHWC2024-01-20
00196449011773A.L.P.S. mvX™Tyber Medical, LLCHWC2024-01-20
00196449011780A.L.P.S. mvX™Tyber Medical, LLCHWC2024-01-20
00196449011797A.L.P.S. mvX™Tyber Medical, LLCHWC2024-01-20
00196449011803A.L.P.S. mvX™Tyber Medical, LLCHWC2024-01-20
00196449011810A.L.P.S. mvX™Tyber Medical, LLCHWC2024-01-20
00196449011827A.L.P.S. mvX™Tyber Medical, LLCHWC2024-01-20
00196449011834A.L.P.S. mvX™Tyber Medical, LLCHWC2024-01-20