FDA.report

Siconus

Primary DI
B030SCL1304000
Brand
Siconus
Company
CAMBER SPINE TECHNOLOGIES, LLC
Model
SCL-130-400
Device description
Ø2.4mm x 400mm Trocar Steinmann Pin
Published
2023-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B030SCL1304000PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthopaedic implant calibration pinA cylindrical rod used preoperatively as a precision guide to align an orthopaedic implant aiming arm with, e.g., an intramedullary bone nail (femoral, humeral, and tibial) that will be implanted. It is inserted through the guiding locking holes of the adjustable aiming arm and its profiled distal tip is engaged into the locking holes of the intramedullary nail providing a given reference point whereby the drill guides and the rest of the aiming arm can be correctly set to correspond with the holes and measurements of the implant. It is typically made of high-grade stainless steel or synthetic materials. Several calibration pins will be used for this procedure. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1 (484) 427-7060quality@cambermedtech.com

Regulatory Flags

DUNS number
054205979
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

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