FDA.report

Prolix

Primary DI
B030CW1110050
Brand
Prolix
Company
CAMBER SPINE TECHNOLOGIES, LLC
Model
CW-111-005
Device description
Box Chisel Assy, 55L
Published
2023-11-02
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
FZOChisel, Surgical, Manual

Product Code Classifications

CodeDeviceSpecialtyClass
FZOChisel, Surgical, ManualGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B030CW1110050PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). 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
false
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B030SCA151807090SPIRA-C IntegratedSCA-1518-07092025-08-04
B030SCA151807100SPIRA-C IntegratedSCA-1518-07102025-08-04
B030SCA151807110SPIRA-C IntegratedSCA-1518-07112025-08-04
B030SCA151807120SPIRA-C IntegratedSCA-1518-07122025-08-04
B030SCA5000010SPIRA-C IntegratedSCA-500-0012025-08-04
B030SCA5040010SPIRA-C IntegratedSCA-504-0012025-08-04
B030SCA5040020SPIRA-C IntegratedSCA-504-0022025-08-04
B030SCZ1034000SPIRA-C IntegratedSCZ-103-4002025-08-04
B030SCZ103400060SPIRA-C IntegratedSCZ-103-400-062025-08-04
B030SCZ103400070SPIRA-C IntegratedSCZ-103-400-072025-08-04
B030SCZ103400080SPIRA-C IntegratedSCZ-103-400-082025-08-04
B030SCZ103400090SPIRA-C IntegratedSCZ-103-400-092025-08-04
B030SCZ103400100SPIRA-C IntegratedSCZ-103-400-102025-08-04
B030SCZ103400110SPIRA-C IntegratedSCZ-103-400-112025-08-04
B030SCZ103400120SPIRA-C IntegratedSCZ-103-400-122025-08-04
B030SCZ1034020SPIRA-C IntegratedSCZ-103-4022025-08-04
B030SCZ1034030SPIRA-C IntegratedSCZ-103-4032025-08-04
B030SCZ1035000SPIRA-C IntegratedSCZ-103-5002025-08-04
B030SCZ1170150SPIRA-C IntegratedSCZ-117-0152025-08-04
B030SCZ1170160SPIRA-C IntegratedSCZ-117-0162025-08-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04052536017546tezoUlrich GmbH & Co. KGFZO2026-03-12
00190776417598MillenniumAvalign Technologies, Inc.FZO2026-03-04
00190776417604MillenniumAvalign Technologies, Inc.FZO2026-03-04
03662663109215Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFZO2026-02-11
03662663109222Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFZO2026-02-11
04058749067538NAFehling Instruments GmbH & Co. KGFZO2026-01-28
04058749075991NAFehling Instruments GmbH & Co. KGFZO2026-01-28
00190776415280MillenniumAvalign Technologies, Inc.FZO2026-01-27
00889024703872Offset Box OsteotomeZimmer, Inc.FZO2025-12-18
03662663271349Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271356Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271363Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271370Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271394Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271400Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271417Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271431Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271455Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271462Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271479Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271493Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271509Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271516Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271523Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271530Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271547Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271554Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271561Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271578Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271585Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18