FDA.reportPublic FDA data

Femoral Head Extractor, 230mm Length

Primary DI
05056405502019
Brand
Femoral Head Extractor, 230mm Length
Company
PLATTS & NISBETT LIMITED
Model
PN0277
Published
2023-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HWBExtractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056405502019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056405502019050564055020195056405502019

GMDN Terms#

Term, Definition table
TermDefinition
Bone awl, reusableA spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
290712512
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
05056405508578Charnley Femoral Prosthesis PusherPN2670PN26702026-02-11
05056405503566Nylon Head Impactor for Femoral Head (spare head for femoral head impactor)PN04752023-09-19
05056405502064Femoral Head Impactor, 204mm O/LPN02832023-09-18
05056405500152Retractor - Travers, CurvedPN0016PN00162025-09-10
05056405520662Sellors KeyPN1831PN18312025-08-27
05056405526398Sellors Retractor Small Blade (Pair)PN2710PN27102025-08-27
05056405526404Sellors Retractor Medium Blade (Pair)PN2711PN27112025-08-27
05056405526411Sellors Retractor Large Blade (Pair)PN2712PN27122025-08-27
05056405527289Sellors - Nut & Bolt (Pair)PN2843PN28432025-08-27
05056405500770Forceps - Lincoln DissectingPN0104PN01042025-07-22
05056405509179Osteotome - Capener, Straight - 6mm Width with Green Soft Grip HandlePN3113PN31132025-05-21
05056405503986Retractor - JuniperPN05572025-01-21
05056405524103Forceps - Rongeur for Cement Extraction (Slide measures 205mm) - 20mm Jaw Width PN23212024-12-16
05056405514135Purse String Forceps, 270mm O/L, 55mm JawPN11992024-12-11
05056405500381Sellors RetractorPN00412024-11-07
05056405501203Murphy Skid Bone LeverPN01652024-10-04
05056405502880Finch Excision Clamp, Hollow Jaw, 235mm O/L, 95mm JawPN03902024-04-15
05056405504235Smith Petersen Osteotome, Curved, 205mm O/L, 13mm Width PN06022024-03-07
05056405508868SPAIRE Hohmann Retractor, Angled, 18mm PN29352023-10-23
05056405508875SPAIRE Iliac Wing RetractorPN29362023-10-23

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Primary DI, Brand, Company table
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00810017915811SABER-XA, Lordosis ExpanderELEVATION SPINE, INC.HWB2026-08-14
00810017915958Slap HammerELEVATION SPINE, INC.HWB2026-08-14
00810017915965Slap Hammer AdaptorELEVATION SPINE, INC.HWB2026-08-14
03701089527965AMPLITUDEAMPLITUDE SASHWB2026-07-29
03701089527972AMPLITUDEAMPLITUDE SASHWB2026-07-29
03701089531276AMPLITUDEAMPLITUDE SASHWB2026-07-29
00889024711495Z1 ExtractorZimmer, Inc.HWB2026-07-20
08800068946966BENCOXCorentec Co., LtdHWB2026-07-01
08800068946973BENCOXCorentec Co., LtdHWB2026-07-01
08800068963666BENCOXCorentec Co., LtdHWB2026-07-01
08806373897344BENCOXCorentec Co., LtdHWB2026-07-01
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08806373897382BENCOXCorentec Co., LtdHWB2026-07-01
10603295543695ATTUNEDEPUY (IRELAND)HWB2025-10-31
00810135963411ImpactNVision Biomedical Technologies, Inc.HWB2025-09-24
00840314269737gSourceGSOURCE LLCHWB2025-05-05
00885556820964General InstrumentsSmith & Nephew, Inc.HWB2023-10-27
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00818069011062TecometTECOMET INC.HWB2023-08-10
00818069011079TecometTECOMET INC.HWB2023-08-10
00818069011086TecometTECOMET INC.HWB2023-08-10
00818069011093TecometTECOMET INC.HWB2023-08-10
00818069011109TecometTECOMET INC.HWB2023-08-10
00818069011116TecometTECOMET INC.HWB2023-08-10