FDA.reportPublic FDA data

Navagio

Primary DI
B07330K0160200
Brand
Navagio
Company
Kalitec Direct LLC
Model
30-K01-6020
Catalog number
30-K01-6020
Device description
Tamp, Straight
Published
2022-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HXGTamp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXGTampOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B07330K0160200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical tamp, reusableA hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
041956211
Device count
1
DM exempt
false
Premarket exempt
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B07315K0112220NIDO Pedicle Screw System15-K01-122215-K01-12222025-03-19
B07315K0112300NIDO Pedicle Screw System15-K01-123015-K01-12302025-03-19
B07315CLA50100NIDO Pedicle Screw System15-CLA-501015-CLA-50102024-09-19
B07315CLA51100NIDO Pedicle Screw System15-CLA-511015-CLA-51102024-09-19
B07330TNS27070Navagio Lumbar Cage30-TNS-270730-TNS-27072024-08-12
B07330TTS27070Navagio Lumbar Cage30-TTS-270730-TTS-27072024-08-12
B07311K0130400Cosmolock11-K01-304011-K01-30402024-06-20
B07315K0120120NIDO Pedicle Screw System15-K01-201215-K01-20122024-05-31
B07315K0120100NIDO Pedicle Screw System15-K01-201015-K01-20102024-05-02
B07315K0170000NIDO Pedicle Screw System15-K01-700015-K01-70002024-03-01
B07310BRS02300Cosmolock10-BRS-023010-BRS-02302024-01-16
B07315BCC05000NIDO Pedicle Screw System15-BCC-050015-BCC-05002023-10-06
B07315BCC05050NIDO Pedicle Screw System15-BCC-050515-BCC-05052023-10-06
B07315BCC05100NIDO Pedicle Screw System15-BCC-051015-BCC-05102023-10-06
B07315BCC05150NIDO Pedicle Screw System15-BCC-051515-BCC-05152023-10-06
B07315BCC05250NIDO Pedicle Screw System15-BCC-052515-BCC-05252023-10-06
B07315BCC05300NIDO Pedicle Screw System15-BCC-053015-BCC-05302023-10-06
B07315BCC05350NIDO Pedicle Screw System15-BCC-053515-BCC-05352023-10-06
B07315BCC05400NIDO Pedicle Screw System15-BCC-054015-BCC-05402023-10-06
B07315BCC05450NIDO Pedicle Screw System15-BCC-054515-BCC-05452023-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776416423MillenniumAvalign Technologies, Inc.HXG2026-02-16
00190776416430MillenniumAvalign Technologies, Inc.HXG2026-02-16
00190376538990Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HXG2026-02-10
00190376694351IdentiTiALPHATEC SPINE, INC.HXG2026-02-10
00190376694368Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HXG2026-02-10
00190376700700IdentiTiALPHATEC SPINE, INC.HXG2026-02-10
00190376700717IdentiTiALPHATEC SPINE, INC.HXG2026-02-10
00810112598902TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHXG2026-02-10
00190776415723MillenniumAvalign Technologies, Inc.HXG2026-02-04
04026575341153Endo-Model Knee Fusion Nail SK InstrumentsWALDEMAR LINK GmbH & Co. KGHXG2026-02-02
00840180543429General InstrumentsALPHATEC SPINE, INC.HXG2025-12-31
00840180543597General InstrumentsALPHATEC SPINE, INC.HXG2025-12-31
00840180543757General InstrumentsALPHATEC SPINE, INC.HXG2025-12-31
03662663155625Zyston Interbody Spacer SystemHighridge Medical, LLCHXG2025-12-29
03662663156707Zyston Interbody Spacer SystemHighridge Medical, LLCHXG2025-12-29
10889981285999FacetSeaspine Orthopedics CorporationHXG2025-12-19
03662663242233Alta ACDF SystemHighridge Medical, LLCHXG2025-12-18
03662663242240Alta ACDF SystemHighridge Medical, LLCHXG2025-12-18
03662663160674Zyston Interbody Spacer SystemHighridge Medical, LLCHXG2025-12-16
03662663160681Zyston Interbody Spacer SystemHighridge Medical, LLCHXG2025-12-16
03662663160698Zyston Interbody Spacer SystemHighridge Medical, LLCHXG2025-12-16
03662663246620Alta ACDF SystemHighridge Medical, LLCHXG2025-12-16
03662663254113Alta ACDF SystemHighridge Medical, LLCHXG2025-12-16
03662663254120Alta ACDF SystemHighridge Medical, LLCHXG2025-12-16
00190376662176IdentiTi IIALPHATEC SPINE, INC.HXG2025-12-08
00199150041930Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXG2025-11-20
03662663070942TMT InstrumentsHighridge Medical, LLCHXG2025-11-16
03662663071581TMT InstrumentsHighridge Medical, LLCHXG2025-11-16
00888480363101C-THRU Anterior Spinal Spacer SystemHighridge Medical, LLCHXG2025-11-14
00888480637370Breckenridge ACDF SystemHighridge Medical, LLCHXG2025-11-14