FDA.report

PECTUS SYSTEM

Primary DI
00841036137151
Brand
PECTUS SYSTEM
Company
BIOMET MICROFIXATION, INC
Model
SP-2092
Catalog number
SP-2092
Published
2016-12-01
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

Contact Domains

Product Codes

CodeName
HXWBENDER

Product Code Classifications

CodeDeviceSpecialtyClass
HXWBenderOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841036137151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036137151008410361371518410361371510841036137151

GMDN Terms

TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(904)741-4400FXJAX-ORDERS@ZIMMERBIOMET.COM

Regulatory Flags

DUNS number
046189866
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 DIBrandModelCatalogPublished
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00888233016902N/ASP-2482SP-24822020-06-16
008882330182272.0MM SYSTEMSP-2640SP-26402020-06-16
00888233078986VENAPAX XLVPX40002025-03-31
00888233012430N/ASP-1634SP-16342020-06-16
00888233013680CMF SYSTEMSP-1883SP-18832020-06-16
00888233013703CMF SYSTEMSP-1884SP-18842020-06-16
00888233013727CMF SYSTEMSP-1885SP-18852020-06-16
00888233013741CMF SYSTEMSP-1886SP-18862020-06-16
00888233025348LactoSorb SystemSP-1688SP-16882020-06-16
00888233025355LactoSorb SystemSP-1689SP-16892020-06-16
00888233025362LactoSorb SystemSP-1690SP-16902020-06-16
00888233025379LactoSorb System - MandibularSP-1778SP-17782020-06-16
00888233025386LactoSorb System - MandibularSP-1779SP-17792020-06-16
00888233025645LactoSorb System - MandibularSP-1944SP-19442020-06-16
00810128536875PECTUS BLU (TM)78-850078-85002024-09-30
00888233077170PECTUS BLU (TM)78-800078-80002024-09-30
00888233077187PECTUS BLU (TM)78-808078-80802024-09-30
00888233077194PECTUS BLU (TM)78-808178-80812024-09-30

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03662663261869BacFix Ti Spinal Fixation SystemHighridge Medical, LLCHXW2025-12-18
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00840493413907RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00840493413914RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00840493413921RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00840493413938RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00840493413945RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00199150044375Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXW2025-11-24
00199150044382Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXW2025-11-24
03662663153379Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663153386Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663153393Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663153409Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663191784Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663214872Vital Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663214889Vital Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663214896Vital Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663146227Gallery Laminoplasty Fixation SystemHighridge Medical, LLCHXW2025-11-15
03662663113410Virage OCT Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-14
03662663131995Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-14
03662663132008Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-14
03662663136785Polaris 4.75 Deformity SystemHighridge Medical, LLCHXW2025-11-14
03662663136792Polaris 4.75 Deformity SystemHighridge Medical, LLCHXW2025-11-14
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