FDA.reportPublic FDA data

NA

Primary DI
00889024088443
Brand
NA
Company
Zimmer, Inc.
Model
47-2357-010-06
Catalog number
47-2357-010-06
Published
2017-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
K050121000
K111039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050121000ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM, MODEL 2357 & 2359Zimmer, Inc.2005-01-31HRS
K111039000ZIMMER PERIARTICULAR LOCKING PLATE SYSTEMZimmer, Inc.2011-05-19HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024088443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024088443008890240884438890240884430889024088443

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, sterileA sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length94Millimeter

Sterilization Methods#

Method table
Method

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024711464Comp Mini Humeral Tray Trial Stem AdapterSSI008664SSI0086642026-08-25
008890247114712.9 JuggerKnot Self-Punching ObturatorSSI008672SSI0086722026-08-25
008890247114882.9 JuggerKnot Self-Punching CannulaSSI008671SSI0086712026-08-25
00889024712294Pin Target AssemblySSI001470SSI0014702026-08-25
00889024712300Z1 POSTERIOR HAMMR ADPTRSSI008666SSI0086662026-08-25
00889024712317Z1 ANTERIOR HAMMR ADPTRSSI008665SSI0086652026-08-25
00889024712843PTH SHELL PSTNR ASSYSSI008611SSI0086112026-08-25
00889024712850PTH SHELL ADPTR SMLLSSI008612SSI0086122026-08-25
00889024712867PTH SHELL ADPTR LRGSSI008658SSI0086582026-08-25
00889024712874PTH BOOMSSI008680SSI0086802026-08-25
00889024712881PTH TROCARSSI008681SSI0086812026-08-25
008890247128986.5/8.0mm Countersink, Cannulated ZH QCSSI008697SSI0086972026-08-25
00889024712904RMR LONG KEYSSI008690SSI0086902026-08-25
00889024712911X BAR RMR ADPT TALLSSI008688SSI0086882026-08-25
00889024712928RMR SHORT KEYSSI008689SSI0086892026-08-25
00889024712935RMR SHORT KEY BENTSSI008691SSI0086912026-08-25
00889024712942RMR LONG KEY BENTSSI008692SSI0086922026-08-25
00889024713277Universal Uni Knee TensorSSI008695SSI0086952026-08-25
00889024713284Right Uni Knee TensorSSI008696SSI0086962026-08-25
00889024713291Left Uni Knee TensorSSI008694SSI0086942026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556836187Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836163Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836170Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836194Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836200Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836217Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836224Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836248Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836255Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836262Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835999Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836002Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836019Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836026Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836033Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836040Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836057Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836064Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836071Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836088Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836095Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836118Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836125Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836132Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836149Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836156Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556838785Total Foot System 2Smith & Nephew, Inc.HRS2022-12-21
00885556838785Total Foot System 2Smith & Nephew, Inc.HWC2022-12-21
00888867007475Arthrex®ARTHREX, INC.HRS2017-02-15
00888867007499Arthrex®ARTHREX, INC.HRS2017-02-15