FDA.reportPublic FDA data

Precision Allograft Cartilage Kit (PACK™)

Primary DI
00191083046990
Brand
Precision Allograft Cartilage Kit (PACK™)
Company
Rti Surgical, Inc.
Model
PAC-A2012
Catalog number
PAC-A2012
Device description
PACK Ring Guide, 12mm
Published
2024-10-14
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
FZXGuide, surgical, instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191083046990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191083046990001910830469901910830469900191083046990

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(386)418-8888labeling@rtix.com

Regulatory Flags#

DUNS number
117560455
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191083047676RapidEase™4564SC4564SC2023-11-03
00191083047683RapidEase™4561SC4561SC2023-11-03
00191083024554Streamline TL Spinal Fixation System10-55-PR-10010-55-PR-1002021-06-25
00191083024585Streamline TL Spinal Fixation System10-55-PR-11510-55-PR-1152021-06-25
00191083024608Streamline TL Spinal Fixation System10-55-PR-12510-55-PR-1252021-06-25
00191083024615Streamline TL Spinal Fixation System10-55-PR-13010-55-PR-1302021-06-25
00191083024639Streamline TL Spinal Fixation System10-55-PR-14010-55-PR-1402021-06-25
00191083024653Streamline TL Spinal Fixation System10-55-PR-15010-55-PR-1502021-06-25
00191083024707Streamline TL Spinal Fixation System10-55-PR-5510-55-PR-552021-06-25
00191083024745Streamline TL Spinal Fixation System10-55-PR-7510-55-PR-752021-06-25
00191083024769Streamline TL Spinal Fixation System10-55-PR-8510-55-PR-852021-06-25
00191083024776Streamline TL Spinal Fixation System10-55-PR-9010-55-PR-902021-06-25
00191083024806Streamline TL Spinal Fixation System10-55-RH-15010-55-RH-1502021-06-25
00191083024844Streamline TL Spinal Fixation System10-55-RHC-20010-55-RHC-2002021-06-25
00191083024851Streamline TL Spinal Fixation System10-55-RHC-40010-55-RHC-4002021-06-25
00191083024868Streamline TL Spinal Fixation System10-55-RHC-60010-55-RHC-6002021-06-25
00191083024875Streamline TL Spinal Fixation System10-55-RR-10010-55-RR-1002021-06-25
00191083024882Streamline TL Spinal Fixation System10-55-RR-11010-55-RR-1102021-06-25
00191083024899Streamline TL Spinal Fixation System10-55-RR-3510-55-RR-352021-06-25
00191083024905Streamline TL Spinal Fixation System10-55-RR-4010-55-RR-402021-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982350633VOLTSynthes GmbHFZX2026-09-25
10886982350640VOLTSynthes GmbHFZX2026-09-25
10886982350657VOLTSynthes GmbHFZX2026-09-25
10886982350664VOLTSynthes GmbHFZX2026-09-25
10886982350671VOLTSynthes GmbHFZX2026-09-25
10886982350688VOLTSynthes GmbHFZX2026-09-25
10886982351098VOLTSynthes GmbHFZX2026-09-25
10886982351104VOLTSynthes GmbHFZX2026-09-25
10886982351111VOLTSynthes GmbHFZX2026-09-25
10886982351128VOLTSynthes GmbHFZX2026-09-25
10886982351135VOLTSynthes GmbHFZX2026-09-25
10886982351142VOLTSynthes GmbHFZX2026-09-25
10886982351692VOLTSynthes GmbHFZX2026-09-25
10886982357182VOLTSynthes GmbHFZX2026-09-25
00190776432164MillenniumAvalign Technologies, Inc.FZX2026-09-22
00810111228527Drill GuideTreace Medical Concepts, Inc.FZX2026-09-21
00190776423896MillenniumAvalign Technologies, Inc.FZX2026-08-26
10886982362988NASynthes GmbHFZX2026-08-26
10886982362995NASynthes GmbHFZX2026-08-26
10886982363008NASynthes GmbHFZX2026-08-26
10886982363015NASynthes GmbHFZX2026-08-26
008890247114712.9 JuggerKnot Self-Punching ObturatorZimmer, Inc.FZX2026-08-25
008890247114882.9 JuggerKnot Self-Punching CannulaZimmer, Inc.FZX2026-08-25
00889024712294Pin Target AssemblyZimmer, Inc.FZX2026-08-25
06937278653598CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278653604CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278653611CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278653628CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654250CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654267CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22