FDA.reportPublic FDA data

ASPIRON S ACP SYSTEM

Primary DI
08800037550866
Brand
ASPIRON S ACP SYSTEM
Company
CG MedTech Co.,Ltd.
Model
FC7330
Published
2021-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800037550866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800037550866088000375508668800037550866

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative bone pin/screw, non-sterileA small non-sterile rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) to bone during an orthopaedic surgical procedure; it is not left in situ after the procedure. It may be wholly- or partially-threaded for screwing into bone, and may have other physical features to enable fixation of surgical instruments. It is made of metallic (e.g., stainless steel) or polymer (radiolucent) material and is available in various shapes and sizes. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688811082
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800308485811ANAX™ OCT SPINAL SYSTEMOSS07502026-05-13
08800037574725Velofix™ SA Cervical CageTS09122026-05-06
08800037574732Velofix™ SA Cervical CageTS09132026-05-06
08800308485804ANAX™ OCT Spinal SystemOS00902026-04-21
08800247357477SECULOK™ ACP SYSTEMFCA10192026-03-31
08800247357484SECULOK™ ACP SYSTEMFCA10212026-03-31
08800247357491SECULOK™ ACP SYSTEMFCA10232026-03-31
08800247357507SECULOK™ ACP SYSTEMFCA10252026-03-31
08800247357514SECULOK™ ACP SYSTEMFCA10272026-03-31
08800247357521SECULOK™ ACP SYSTEMFCA10292026-03-31
08800247357538SECULOK™ ACP SYSTEMFCA10312026-03-31
08800247357545SECULOK™ ACP SYSTEMFCA10332026-03-31
08800247357552SECULOK™ ACP SYSTEMFCA10352026-03-31
08800247357569SECULOK™ ACP SYSTEMFCA10372026-03-31
08800247357576SECULOK™ ACP SYSTEMFCA10392026-03-31
08800247357583SECULOK™ ACP SYSTEMFCA10412026-03-31
08800247357590SECULOK™ ACP SYSTEMFCA10432026-03-31
08800247357606SECULOK™ ACP SYSTEMFCA10452026-03-31
08800247357613SECULOK™ ACP SYSTEMFCA20312026-03-31
08800247357620SECULOK™ ACP SYSTEMFCA20332026-03-31

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