FDA.reportPublic FDA data

N/A

Primary DI
00643169328716
Brand
N/A
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
3002933
Device description
TEMPLATE 3002933 ZEVO 33MM 2 LVL
Published
2017-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169328716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169328716006431693287166431693287160643169328716

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (K-wire), it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a non-bioabsorbable material (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
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
00763000891503CD HORIZON Spinal System559006195502026-09-28
00763000891527CD HORIZON Spinal System559006101502026-09-28
00763000891541CD HORIZON Spinal System559016101502026-09-28
00763000891558CD HORIZON Spinal System559016101602026-09-28
00763000891572CD HORIZON Spinal System559016175502026-09-28
00763000891589CD HORIZON Spinal System559016175602026-09-28
00763000891602CD HORIZON Spinal System559016185502026-09-28
00763000891619CD HORIZON Spinal System559016185602026-09-28
00763000891626CD HORIZON Spinal System559016195502026-09-28
00763000891633CD HORIZON Spinal System559016195602026-09-28
00763000992521INFINITY OCT SystemG36535102026-09-26
00763000992552INFINITY OCT SystemG36535162026-09-26
00643169016798Medtronic Reusable InstrumentsX06110012022-11-27
00643169016804Medtronic Reusable InstrumentsX06110022022-11-27
00673978816241Medtronic Reusable InstrumentsX06990402022-11-27
00613994423559N/AX07072142022-11-14
00613994423566N/AX07072152022-11-14
00613994423573N/AX07072162022-11-14
00613994423603N/AX07072192022-11-14
00643169588219Medtronic Resuable InstrumentsX08108352022-11-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982350596VOLTSynthes GmbHHWT2026-09-25
10886982350602VOLTSynthes GmbHHWT2026-09-25
10886982350619VOLTSynthes GmbHHWT2026-09-25
10886982350626VOLTSynthes GmbHHWT2026-09-25
10886982350695VOLTSynthes GmbHHWT2026-09-25
10886982350701VOLTSynthes GmbHHWT2026-09-25
10886982350718VOLTSynthes GmbHHWT2026-09-25
00840606191326PrimusSPINAL ELEMENTS, INC.HWT2026-09-22
03701313009502K-RODS.M.A.I.OHWT2026-09-22
00810112599534PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599541PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599558PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599565PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599572PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599589PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599596PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599602PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599619PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599626PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599633PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599640PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599657PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599664PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599671PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599688PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599695PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599701PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599718PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599343PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-07
00810112599350PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-07