FDA.report

ANAX™ 5.5 SPINAL SYSTEM

Primary DI
08800015972833
Brand
ANAX™ 5.5 SPINAL SYSTEM
Company
Innosys Co., Ltd.
Model
SFM0090
Published
2018-01-31
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

Related Records

Product Codes

CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800015972833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800015972833088000159728338800015972833

GMDN Terms

TermDefinition
Orthopaedic implantable-device cutterA heavy-duty manual surgical instrument designed to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). The cutting is typically performed with a shearing action. It may be a hand-held or a table mounted device. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
688811082
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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 DIBrandModelCatalogPublished
08800037597892UniSpace® Stand-Alone C CageAUS10092024-12-07
08800037597908UniSpace® Stand-Alone C CageAUS10102024-12-07
08800037597915UniSpace® Stand-Alone C CageAUS10112024-12-07
08800037597922UniSpace® Stand-Alone C CageAUS10122024-12-07
08800037597939UniSpace® Stand-Alone C CageAUS10132024-12-07
08800037597946UniSpace® Stand-Alone C CageAUS10142024-12-07
08800247357088GENERAL HANDLEGH11202024-12-07
08800247357095GENERAL HANDLEGH11302024-12-07
08800247356920INNOVERSE SPINAL SYSTEMNP09112024-12-02
08800247356937INNOVERSE SPINAL SYSTEMNP09122024-12-02
08800247356944INNOVERSE SPINAL SYSTEMNP09132024-12-02
08800247356951INNOVERSE SPINAL SYSTEMNP09142024-12-02
08800247356968INNOVERSE SPINAL SYSTEMNP09152024-12-02
08800247356975INNOVERSE SPINAL SYSTEMNP09162024-12-02
08800247356982INNOVERSE SPINAL SYSTEMNP09172024-12-02
08800247356999INNOVERSE SPINAL SYSTEMNP09212024-12-02
08800247357002INNOVERSE SPINAL SYSTEMNP09222024-12-02
08800247357019INNOVERSE SPINAL SYSTEMNP09232024-12-02
08800247357026INNOVERSE SPINAL SYSTEMNP09242024-12-02
08800247357033INNOVERSE SPINAL SYSTEMNP09312024-12-02

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00850075235179TESA Tensioner SystemTesa Medical, Inc.FSM2026-05-26
10889950157326Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-05-26
00888118150240PURE PECTUSKLS-Martin L.P.FSM2026-05-25
00888118150257PURE PECTUSKLS-Martin L.P.FSM2026-05-25
00888118150264PURE PECTUSKLS-Martin L.P.FSM2026-05-25
00888118150448IXOSKLS-Martin L.P.FSM2026-05-25
00888118150455IXOSKLS-Martin L.P.FSM2026-05-25
00888118150462IXOSKLS-Martin L.P.FSM2026-05-25
00888118150479IXOSKLS-Martin L.P.FSM2026-05-25
00888118150486IXOSKLS-Martin L.P.FSM2026-05-25
00888118150493IXOSKLS-Martin L.P.FSM2026-05-25
00888118153029L1 STERNALKLS-Martin L.P.FSM2026-05-25
00888118153050IXOSKLS-Martin L.P.FSM2026-05-25
00888118153067IXOSKLS-Martin L.P.FSM2026-05-25
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00888118153081IXOSKLS-Martin L.P.FSM2026-05-25
00888118154613LEVEL ONEKLS-Martin L.P.FSM2026-05-25
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