FDA.reportPublic FDA data

N/A

Primary DI
00889024126886
Brand
N/A
Company
Zimmer, Inc.
Model
6521-53
Published
2017-01-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTZCALIPER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTZCaliperOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024126886PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024126886008890241268868890241268860889024126886

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone calliperA hand-held manual surgical instrument consisting of two legs hinged at one end designed to measure various bone dimensions (e.g., diameter or length) required for orthopaedic procedures. It has an attached scale to indicate the measured units. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
056038268
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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
00840180545706General InstrumentsALPHATEC SPINE, INC.KTZ2026-05-15
00840180545713General InstrumentsALPHATEC SPINE, INC.KTZ2026-05-15
00840343727338GEN2SURGIX MEDICAL LLCKTZ2026-04-16
09348811099037INKAThe Trustee for KAISER FAMILY TRUSTKTZ2026-04-10
09348811099044INKAThe Trustee for KAISER FAMILY TRUSTKTZ2026-03-18
00840311245680Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.KTZ2026-03-18
G079C5080000100MIS Golden Isles Pedicle Screw System Intelivation, LLCKTZ2026-01-30
00840180545287General InstrumentsALPHATEC SPINE, INC.KTZ2026-01-29
00190376680408ProximityALPHATEC SPINE, INC.KTZ2025-12-19
03662663244701Vital MIS Spinal Fixation SystemHighridge Medical, LLCKTZ2025-12-18
03662663244800Vital MIS Spinal Fixation SystemHighridge Medical, LLCKTZ2025-12-18
00887868457180Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCKTZ2025-11-14
00888480500834Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCKTZ2025-11-14
03662663131957Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCKTZ2025-11-14
03662663194020PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCKTZ2025-11-14
03662663194037PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCKTZ2025-11-14
03662663109925InViZia Anterior Cervical Plate SystemHighridge Medical, LLCKTZ2025-11-12
03662663126137Vital Spinal Fixation SystemHighridge Medical, LLCKTZ2025-11-07
00763000684112N/AMEDTRONIC SOFAMOR DANEK, INC.KTZ2025-09-08
00194613115111MSI Precision Specialty InstrumentsMed Saver, Inc.KTZ2025-08-01
00190376585628InvictusALPHATEC SPINE, INC.KTZ2025-05-01
04719886908275USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KTZ2025-04-30
00194613050023MSI Precision Specialty InstrumentsMed Saver, Inc.KTZ2025-03-21
00194613081515MSI Precision Specialty InstrumentsMed Saver, Inc.KTZ2025-03-21
00763000864675n/aMEDTRONIC SOFAMOR DANEK, INC.KTZ2025-03-11
09421028119290Kinematic Alignment Caliper – S+NENZTEC LIMITEDKTZ2025-01-24
00840306823749Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KTZ2025-01-17
00840306823756Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KTZ2025-01-17
00840306823831Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KTZ2025-01-17
00840306821509Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KTZ2025-01-16