FDA.reportPublic FDA data

IJS-E (Twin)

Primary DI
00841506114859
Brand
IJS-E (Twin)
Company
SKELETAL DYNAMICS L.L.C.
Model
IJS
Catalog number
DRLL-CDC-37030
Device description
Drill, Cannulated, 3.7mm x 30mm
Published
2023-06-20
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841506114859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841506114859008415061148598415061148590841506114859

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, single-useA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter3.7Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(305)596-7585feedback@skeletaldynamics.com

Regulatory Flags#

DUNS number
869056148
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
00841506141442Distal Elbow Plating SystemFreeFix, Proximal Ulna Plate, 7 Slot, RightPUPF-7SR2026-03-05
00841506141459Distal Elbow Plating SystemFreeFix, Proximal Ulna Plate, 7 Slot, LeftPUPF-7SL2026-03-05
00841506141466Distal Elbow Plating SystemFreeFix, Proximal Ulna Plate, 8 Slot, RightPUPF-8SR2026-03-05
00841506141473Distal Elbow Plating SystemFreeFix, Proximal Ulna Plate, 8 Slot, LeftPUPF-8SL2026-03-05
00841506141480Distal Elbow Plating SystemFreeFix, Proximal Ulna Plate, 8 Slot Plus, RightPUPF-8SPR2026-03-05
00841506141497Distal Elbow Plating SystemFreeFix, Proximal Ulna Plate, 8 Slot Plus, LeftPUPF-8SPL2026-03-05
00841506117621GeminusRadial Hook Plate Guide, RightGMN-HPG-RR2026-01-21
00841506117638GeminusRadial Hook Plate Guide, LeftGMN-HPG-RL2026-01-21
00841506117645GeminusUlnar Hook Plate GuideGMN-HPG-UB2026-01-21
00841506117652GeminusGEMINUS Hook Plate, Radial, RightGMN-HP-RR2026-01-21
00841506117669GeminusGEMINUS Hook Plate, Radial, LeftGMN-HP-RL2026-01-21
00841506142333GeminusButtress Button, 6.35mm Round, 0.6mm x 152mmBB-RND-012026-01-21
00841506142340GeminusWire Guide, Tapered, 0.9mm x 152mmWG-ST-091522026-01-21
00841506142364GeminusWire Cutter, Small, AngledINST-WC-SM2026-01-21
00841506142708GeminusMarginal Fragment ModuleGMN-MF-MOD2026-01-21
00841506112763ProteanCMC Osteotomy Cutting GuidePRT-CTG-CMC2025-12-01
00841506113050ProteanPROTEAN Fragment Plate, CMCPRT-MFP-CMC2025-12-01
00841506136028ProteanScrew, Variable Angle Locking, 2.5mm x 6mm, CoCrVAL-25060-CC2025-12-01
00841506136035ProteanScrew, Variable Angle Locking, 2.5mm x 7mm, CoCrVAL-25070-CC2025-12-01
00841506136042ProteanScrew, Variable Angle Locking, 2.5mm x 8mm, CoCrVAL-25080-CC2025-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024700116CROSSLOCK NARROW BLOCK LEFTBiomet Orthopedics, LLCLXT2025-12-01
00889024700123CROSSLOCK STD BLOCK RIGHTBiomet Orthopedics, LLCLXT2025-12-01
00889024700130CROSSLOCK NARROW BLOCK RIGHTBiomet Orthopedics, LLCLXT2025-12-01
00889024700147CROSSLOCK WIDE BLOCK RIGHTBiomet Orthopedics, LLCLXT2025-12-01
00889024700154CROSSLOCK STD BLOCK LEFTBiomet Orthopedics, LLCLXT2025-12-01
00889024700161CROSSLOCK WIDE BLOCK LEFTBiomet Orthopedics, LLCLXT2025-12-01
09348215127558CR Peg Multi ToolSIGNATURE ORTHOPAEDICS PTY LTDLXT2025-04-09
18052469475966ORTHOFIXORTHOFIX SRLLXT2024-01-31
00885556819791UNI-CP Compression PlateSmith & Nephew, Inc.LXT2023-10-26
18053504366850TRUELOK SYSTEMORTHOFIX SRLLXT2023-07-31
18053504366867TRUELOK SYSTEMORTHOFIX SRLLXT2023-07-31
00841506105734IJS-ESKELETAL DYNAMICS L.L.C.LXT2023-06-20
00841506107226IJS-ESKELETAL DYNAMICS L.L.C.LXT2023-06-20
00841506130767IJSSKELETAL DYNAMICS L.L.C.LXT2023-06-20
00841506131559IJSSKELETAL DYNAMICS L.L.C.LXT2023-06-20
00841506132877IJSSKELETAL DYNAMICS L.L.C.LXT2023-06-20
00841506132891IJSSKELETAL DYNAMICS L.L.C.LXT2023-06-20
00841506132907IJSSKELETAL DYNAMICS L.L.C.LXT2023-06-20
00841506132914IJSSKELETAL DYNAMICS L.L.C.LXT2023-06-20
00841506132938IJSSKELETAL DYNAMICS L.L.C.LXT2023-06-20
18052469476437TRUELOK SYSTEMORTHOFIX SRLLXT2023-04-28
00885556839942Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21
00885556839966Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21
00885556839973Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21
00885556839980Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21
00885556840009Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21
00885556840023Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21
00885556840030Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21
00885556840047Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21
00885556840054Total Wrist Fusion SystemSmith & Nephew, Inc.LXT2022-12-21