FDA.reportPublic FDA data

Enztec Modular Planer 45mm – 8.10mm ID

Primary DI
09421038413821
Brand
Enztec Modular Planer 45mm – 8.10mm ID
Company
ENZTEC LIMITED
Model
4251-8245
Catalog number
4251-8245
Device description
A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
Published
2026-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421038413821PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421038413821094210384138219421038413821

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
592616445
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421038413753Enztec Modular Planer Handle - Zimmer4251-80014251-80012026-10-30
09421038413760Enztec Modular Planer Handle - Large AO4251-80024251-80022026-10-30
09421038413777Enztec Modular Planer Handle - Hudson4251-80034251-80032026-10-30
09421038413784Enztec Modular Planer 38mm – 7.10mm ID4251-80384251-80382026-10-30
09421038413791Enztec Modular Planer 38mm – 8.00mm ID4251-81384251-81382026-10-30
09421038413807Enztec Modular Planer 45mm – 7.10mm ID4251-80454251-80452026-10-30
09421038413814Enztec Modular Planer 45mm – 8.00mm ID4251-81454251-81452026-10-30
09421038413838Enztec Modular Planer 38mm – 8.10mm ID4251-82384251-82382026-10-30
09421028119184Enztec Partial Knee Femoral Impactor - Angled Arm4240-33014240-33012026-10-07
09421028119191Enztec Partial Knee Femoral Impactor with Slap Hammer - Angled Arm4240-33024240-33022026-10-07
09421028110853Tensioner, AP Sizer2120.00.0002120.00.0002026-07-30
09421028110877Tensioner, Balancer2118.00.0002118.00.0002026-07-30
09421028110884Tensioner, Distractor2119.00.0002119.00.0002026-07-30
09421038412237KA Femoral Alignment Guide293-777293-7772026-06-24
09421038412244KA Femoral Alignment Guide - Medial Paddle293-778293-7782026-06-24
09421038412251KA Femoral Alignment Guide - Lateral Paddle293-779293-7792026-06-24
09421038412268KA Femoral Alignment Guide - Fan293-780293-7802026-06-24
09421038412275KA Femoral Alignment Guide – IM Guide293-781293-7812026-06-24
09421038412282KA Femoral Alignment Guide – Pin Guide Connector293-782293-7822026-06-24
09421038413159Reamer, Acetabular, 36mm Full5900-RF365900-RF362026-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000777418CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-11-01
00763000777517CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-11-01
00763000777524CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-11-01
00763000774165CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774172MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774189MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774196MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774202MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774226MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774240MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774257MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774301MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000777692MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000777739MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
09421038413753Enztec Modular Planer Handle - ZimmerENZTEC LIMITEDHWE2026-10-30
09421038413760Enztec Modular Planer Handle - Large AOENZTEC LIMITEDHWE2026-10-30
09421038413777Enztec Modular Planer Handle - HudsonENZTEC LIMITEDHWE2026-10-30
09421038413784Enztec Modular Planer 38mm – 7.10mm IDENZTEC LIMITEDHWE2026-10-30
09421038413791Enztec Modular Planer 38mm – 8.00mm IDENZTEC LIMITEDHWE2026-10-30
09421038413807Enztec Modular Planer 45mm – 7.10mm IDENZTEC LIMITEDHWE2026-10-30
09421038413814Enztec Modular Planer 45mm – 8.00mm IDENZTEC LIMITEDHWE2026-10-30
09421038413838Enztec Modular Planer 38mm – 8.10mm IDENZTEC LIMITEDHWE2026-10-30
04250337121794"Shrill® Deflector Shaft 2, WL= 320mm, reusable"Joimax GmbHHWE2026-10-29
04250337122388Deflector Bone Resector, Bullet-Tip, disposableJoimax GmbHHWE2026-10-29
04250337122395Deflector Diamond Abrasor, disposableJoimax GmbHHWE2026-10-29
04250337122401Deflector Bone Resector, Ball-Tip, disposableJoimax GmbHHWE2026-10-29
00763000777500MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-25
00763000777623MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-25
00763000786434MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-25
00763000777616CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-23