FDA.reportPublic FDA data

Meniscus Allograft Transplantation (MAT)

Primary DI
00191083044569
Brand
Meniscus Allograft Transplantation (MAT)
Company
Rti Surgical, Inc.
Model
999011
Catalog number
999011
Device description
Drill Chuck
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
HXYBRACE, DRILL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXYBrace, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191083044569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191083044569001910830445691910830445690191083044569

GMDN Terms#

Term, Definition table
TermDefinition
Manual surgical rotary handpiece, reusableA manually-powered, hand-held, surgical device intended to be used to provide rotary motion for an endpiece (not included) during a surgical procedure such as cutting, sculpting, trepanning, or drilling bone and driving Kirschner wires; it is not dedicated to a specific clinical procedure. It is available in two main designs: 1) a U-shaped drill brace powered by the surgeon who holds the top of the brace steady whilst rotating it with horizontal crankshaft-like movements; or 2) a drill powered by the rotation of a side-mounted handle, and which may be cannulated to allow for use of a guidewire. Both types may have a Jacobs chuck or collet to hold the drill bit. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191083045092RegenaVate™ Formable DBM, 1cm x 4cm x 0.5cm, 2ccZR0302001510Z2024-05-27
00191083045108RegenaVate™ Formable DBM RT, 1ccZR0201005301Z2024-05-27
00191083045078RegenaVate™ Formable DBM, 1cm x 1cm x 0.5cm, 0.5ccZR0305001504Z2024-05-27
00191083045085RegenaVate™ Formable DBM, 1cm x 2cm x 0.5cm, 1ccZR0301001505Z2024-05-27
00191083045115RegenaVate™ Formable DBM RT, 2ccZR0202005302Z2024-05-27
10885862093196OPTEFORM® Allograft Full Disc, 3 x 20mm, 1cc002523600-03-202015-11-06
10885862093202OPTEFORM® Allograft Disc, 30mm x 3mm, 2cc002530600-03-302015-11-06
10885862093219OPTEFORM® Allograft Disc, 45mm x 5mm, 8cc002545600-05-452015-11-06
10885862093226OPTEFORM® Allograft Full Disc, 5 x 90mm, 32cc002529600-05-902015-11-06
10885862094094OPTEFORM® Allograft Partial Disc, 75mm x 5mm, 15cc002575602-05-752015-11-06
10885862094100OPTEFORM® Allograft Partial Disc, 90mm x 5mm, 22cc002590602-05-902015-11-06
10885862094223OPTEFORM® Allograft Paste, 2cc005102606-01-022015-11-06
10885862094230OPTEFORM® Allograft Paste, 5cc005105606-01-052015-11-06
10885862094247OPTEFORM® Allograft Paste, 10cc005110606-01-102015-11-06
10885862094254OPTEFORM® Allograft Paste, 20cc005120606-01-202015-11-06
10885862094384OPTEFIL® Allograft Paste, 1cc005001616-01-012015-11-06
10885862094391OPTEFIL® Allograft Paste, 5cc005005616-01-052015-11-06
10885862094407OPTEFIL® Allograft Paste, 10cc005010616-01-102015-11-06
10885862094599Synergent™ DBM, 1cc004901630-00-012015-11-06
10885862094605Synergent™ DBM, 5cc004905630-00-052015-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862605764EPICExactech, Inc.HXY2026-04-28
05055662970593ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-08-14
05055662971293Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
05055662971309Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
05055662971316Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
05055662971323Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
00889024682399PSN TM TIB DRILL GDEZimmer, Inc.HXY2025-01-13
00810027271594Citrelock ACL Tibial Drill Guide, Flat HookAcuitive Technologies, Inc.HXY2024-12-03
04049197096812RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-07-16
04049197096744RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-07-15
04026575534678LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGHXY2024-07-11
04026575534739LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGHXY2024-07-11
04049197187848RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-06-28
00840183516031BR Surgical, LLCBR Surgical, LLCHXY2024-06-03
00840183516048BR Surgical, LLCBR Surgical, LLCHXY2024-06-03
M73910290060TransFasten-LSF, Offset GuideCAPTIVA SPINE, INC.HXY2024-04-25
M73910290130TransFasten - LSF, Sharp Guide Pin Ø3.2mm x 229mmCAPTIVA SPINE, INC.HXY2024-04-25
M73910290140TransFasten - LSF, Blunt Guide Pin Ø3.2mm x 229mmCAPTIVA SPINE, INC.HXY2024-04-25
M73910290150TransFasten - LSF, Blunt Guide Pin Ø3.2mm x 457mmCAPTIVA SPINE, INC.HXY2024-04-25
M73910290170TransFasten - LSF, Open-Ended Offset GuideCAPTIVA SPINE, INC.HXY2024-04-25
M73910290180TransFasten - LSF, Parallel GuideCAPTIVA SPINE, INC.HXY2024-04-25
05055662969825COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969832COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969849COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969856COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969863COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969870COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
M7392030002104-Hole Drill GuideCAPTIVA SPINE, INC.HXY2024-03-11
08033860019105BIOPSYBELLBIOPSYBELL SRLHXY2024-02-23
08033860019112BIOPSYBELLBIOPSYBELL SRLHXY2024-02-23