FDA.reportPublic FDA data

Protean

Primary DI
00841506138084
Brand
Protean
Company
SKELETAL DYNAMICS L.L.C.
Model
Driver, T6
Catalog number
DRVR-UQC-T6
Device description
Driver, T6
Published
2025-12-01
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXXSCREWDRIVER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841506138084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841506138084008415061380848415061380840841506138084

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

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
true
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
true
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
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00190776418328MillenniumAvalign Technologies, Inc.HXX2026-03-23
00199150039524n/aMEDTRONIC SOFAMOR DANEK, INC.HXX2026-03-22
00199150067459Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-03-20
B922F004800208ACURA Stabilization SystemINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITEDHXX2026-03-11
G832F00500340ACURA Stabilization SystemBioalign Inc.HXX2026-03-09
G832F00503040ACURA Stabilization SystemBioalign Inc.HXX2026-03-09
00840194498975Response 5.5/6.0ORTHOPEDIATRICS CORP.HXX2026-03-03
00840194498982Response 5.5/6.0ORTHOPEDIATRICS CORP.HXX2026-03-03
00810076338545Momentum MIS - Modified InstrumentUlrich Medical Usa, Inc.HXX2026-03-02
00199150066902Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-02-28
03662663128780PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCHXX2026-02-11
03662663129084Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXX2026-02-11
00810112597493TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHXX2026-02-10
00810112599756TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHXX2026-02-10
10886982351586NASynthes GmbHHXX2026-02-10
10886982351593NASynthes GmbHHXX2026-02-10
00840180545225General InstrumentsALPHATEC SPINE, INC.HXX2026-01-29
10885862657060CSBExactech, Inc.HXX2026-01-28
00840194498128Response Spine SystemORTHOPEDIATRICS CORP.HXX2026-01-22
00888118145871LEVEL ONEKLS-Martin L.P.HXX2026-01-19
08800308499696INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HXX2026-01-19
07640332471548PERLA ® TLSpineArt SAHXX2026-01-05
00840180543917General InstrumentsALPHATEC SPINE, INC.HXX2025-12-31
00840194495189Response 5.5/6.0ORTHOPEDIATRICS CORP.HXX2025-12-31
00199150060115Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2025-12-29
00199150062898Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2025-12-29
00888480489849Solitaire Cervical Spacer SystemHighridge Medical, LLCHXX2025-12-29
00888480489856Solitaire Cervical Spacer SystemHighridge Medical, LLCHXX2025-12-29