FDA.reportPublic FDA data

Punch Awl

Primary DI
B806RO0017PASZ0
Brand
Punch Awl
Company
Spineup, Inc.
Model
RO0017PASZ
Catalog number
RO0017PASZ
Device description
Punch Awl
Published
2024-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWJAwl

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B806RO0017PASZ0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone awl, reusableA spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
786-910-0234contact@upgroup.tech

Regulatory Flags#

DUNS number
116999578
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B806RO2100V1080Ball Joint Tap with Stop D3.5xL08RO2100V108RO2100V1082024-09-17
B806RO2101V1090Ball Joint Tap with Stop D3.5xL09RO2101V109RO2101V1092024-09-17
B806RO2102V1100Ball Joint Tap with Stop D3.5xL10RO2102V110RO2102V1102024-09-17
B806RO2103V1110Ball Joint Tap with Stop D3.5xL11RO2103V111RO2103V1112024-09-17
B806RO2104V1120Ball Joint Tap with Stop D3.5xL12RO2104V112RO2104V1122024-09-17
B806RO2105V1130Ball Joint Tap with Stop D3.5xL13RO2105V113RO2105V1132024-09-17
B806RO2106V1140Ball Joint Tap with Stop D3.5xL14RO2106V114RO2106V1142024-09-17
B806RO2107V1150Ball Joint Tap with Stop D3.5xL15RO2107V115RO2107V1152024-09-17
B806RO2108V1160Ball Joint Tap with Stop D3.5xL16RO2108V116RO2108V1162024-09-17
B806RO2109V1170Ball Joint Tap with Stop D3.5xL17RO2109V117RO2109V1172024-09-17
B806RO2110V1180Ball Joint Tap with Stop D3.5xL18RO2110V118RO2110V1182024-09-17
B806RO2111V1190Ball Joint Tap with Stop D3.5xL19RO2111V119RO2111V1192024-09-17
B806RO2112V1200Ball Joint Tap with Stop D3.5xL20RO2112V120RO2112V1202024-09-17
B806RO0002LFIX0Romero Lateral Finishing Impactor XLRO0002LFIXRO0002LFIX2024-10-14
B806RO0027FIZZ0Romero Finishing ImpactorRO0027FIZZRO0027FIZZ2024-10-14
B806RO0028LFIZ0Romero Lateral Finishing ImpactorRO0028LFIZRO0028LFIZ2024-10-14
B806ISRO1214L08CA10ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD12xH08ISRO1214L08CA1ISRO1214L08CA12023-10-03
B806ISRO1420L13CA10ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD14xH13ISRO1420L13CA1ISRO1420L13CA12023-10-04
B806ISRO1620A12CA10ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH12ISRO1620A12CA1ISRO1620A12CA12023-10-03
B806ISRO1214A04CB10ROMERO CERVICAL CAGE, W14xD12xH04ISRO1214A04CB1ISRO1214A04CB12023-08-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311245376Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HWJ2026-04-30
04048844406547n/aimplantcast GmbHHWJ2026-04-07
04052536216161uCentumUlrich GmbH & Co. KGHWJ2026-03-31
00860015151308EnFix Instrument Kit - CompleteTETROUS, INC.HWJ2026-02-24
00887868287473Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCHWJ2025-11-12
03662663108126Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCHWJ2025-11-12
03662663109949InViZia Anterior Cervical Plate SystemHighridge Medical, LLCHWJ2025-11-12
03662663128759PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCHWJ2025-11-12
03662663129015Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHWJ2025-11-12
07640375234773SCARLET AL-T INSTRUMENTATIONSpineArt SAHWJ2025-11-10
08059386744338Orthopaedic Surgical InstrumentsCITIEFFE SRLHWJ2025-11-06
00763000674410n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-26
09120129291507Awl, Curved, CannulatedI.T.S. GmbHHWJ2025-10-21
09120129291514Awl TrocarI.T.S. GmbHHWJ2025-10-21
00763000878245n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-20
00840180541050General InstrumentsALPHATEC SPINE, INC.HWJ2025-10-17
00763000885243n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-11
00816342025522AWLPARCUS MEDICAL LLCHWJ2025-09-16
04047844128190CYLOX STSIGNUS Medizintechnik GmbHHWJ2025-05-27
04047844128206CYLOX STSIGNUS Medizintechnik GmbHHWJ2025-05-27
00841732134393GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732134409GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
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00841732134423GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732135406GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732139411GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732139428GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732163850GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-09-14
00841732163935GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-09-14
008100747560374WEB Medical4web MedicalHWJ2023-02-13