FDA.report

Pro-X1

Primary DI
05397283000304
Brand
Pro-X1
Company
X-BOLT ORTHOPEDICS INC.
Model
XBT032001
Device description
Ø3.2mm x 390mm Femoral Head K-wire
Published
2024-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05397283000304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05397283000304053972830003045397283000304

GMDN Terms

TermDefinition
Orthopaedic intraoperative positioning pin, single-useA nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a single-use device.

Device Sizes

TypeValueUnit
Length390Millimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
119116284
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05397283000007Pro-X1XNI-100-X2024-08-27
05397283000014Pro-X1XNI-200-Y2024-08-27
05397283000021Pro-X1XNI-0022024-08-27
05397283000038Pro-X1XNI-0032024-08-27
05397283000045Pro-X1XNI-0042024-08-27
05397283000052Pro-X1XNI-0052024-08-27
05397283000069Pro-X1XNI-0062024-08-27
05397283000076Pro-X1XNI-0072024-08-27
05397283000083Pro-X1XNI-0082024-08-27
05397283000090Pro-X1XNI-0092024-08-27
05397283000113Pro-X1XNI-0122024-08-27
05397283000120Pro-X1XNI-0142024-08-27
05397283000137Pro-X1XNI-0152024-08-27
05397283000144Pro-X1XNI-0162024-08-27
05397283000168Pro-X1XNI-0182024-08-27
05397283000175Pro-X1XNI-0192024-08-27
05397283000182Pro-X1XNI-0202024-08-27
05397283000199Pro-X1XNI-0212024-08-27
05397283000205Pro-X1XNI-0222024-08-27
05397283000212Pro-X1XNI-0232024-08-27

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00887868150371Affixus®Zimmer, Inc.HSB2026-03-19
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00887868150609Affixus®Zimmer, Inc.HSB2026-03-19
00887868150616Affixus®Zimmer, Inc.HSB2026-03-19
00887868150883Affixus®Zimmer, Inc.HSB2026-03-19
00887868150890Affixus®Zimmer, Inc.HSB2026-03-19
00887868150906Affixus®Zimmer, Inc.HSB2026-03-19
00887868150913Affixus®Zimmer, Inc.HSB2026-03-19
00887868150920Affixus®Zimmer, Inc.HSB2026-03-19
00889024700253Affixus®Zimmer, Inc.HSB2026-03-19
00889024700260Affixus®Zimmer, Inc.HSB2026-03-19
00889024700277Affixus®Zimmer, Inc.HSB2026-03-19
00889024700284Affixus®Zimmer, Inc.HSB2026-03-19
00889024700291Affixus®Zimmer, Inc.HSB2026-03-19
00888867463363Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529069Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529076Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529137Arthrex®ARTHREX, INC.HSB2026-03-16