FDA.reportPublic FDA data

ACTIVATION TOOL

Primary DI
00848665010916
Brand
ACTIVATION TOOL
Company
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
Model
S0457
Published
2016-03-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848665010916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848665010916008486650109168486650109160848665010916

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, single-use, sterileA sterile, non-powered tool that fits into a screw head in order to apply rotation to tighten/loosen/remove a screw during a surgical procedure. It typically has a high-grade stainless steel shaft with a distal end dedicated to fit into a screw head that may be slotted, Phillips (cross head), Pozidriv (Supadriv), Torx, Hex (Allen), Robertson (square), spanner head (twin pins), Polydrive, or one-way (clutch). The proximal end of the shaft may have a handle for manual use, or it may have a profiled tang that fits into an interchangeable screwdriver handle, a manually-operated chuck, or a power driver. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117858154
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848665004021AOS CAPTURED BULLET TIP END CAP, TROCHANTERIC NAIL 1mmS1047-0192015-12-02
00848665004052AOS CAPTURED BULLET TIP END CAP, TROCHANTERIC NAIL 5mmS1047-0592015-12-02
00848665004083AOS CAPTURED BULLET TIP END CAP, TROCHANTERIC NAIL 10mmS1047-1092015-12-02
00848665004106AOS CAPTURED END CAP WITH POST 1mmS1048-0192015-12-02
00848665004823AOS END CAP, HUMERAL NAIL 2mmS1074-0202015-12-04
00848665004830AOS END CAP, HUMERAL NAIL 5mmS1074-0502015-12-05
00848665005332AOS END CAP, TIBIAL NAIL 5mmS1115-0502015-12-15
00848665005349AOS END CAP, TIBIAL NAIL 10mmS1115-1002015-12-15
00848665005356AOS END CAP, TIBIAL NAIL COMPRESSIONS11162015-12-15
00848665005363AOS SPACER, STATIC LOCKING TIBIAL NAILS11172015-10-14
00848665005745AOS FRACTURE REDUCTION SCREW HUMERAL NAILS11752015-10-12
00848665012521AOS END CAP, ANTEGRADE FEMORAL NAIL 5.0mmS1322-0052015-10-19
00848665012538AOS END CAP, ANTEGRADE FEMORAL NAIL 10.0mmS1322-0102015-12-18
00848665012545AOS END CAP, ANTEGRADE FEMORAL NAIL 15.0mmS1322-0152015-12-18
00848665012552AOS LOCKING END CAP, ANTEGRADE FEMORAL NAIL 0mmS13232015-12-18
00848665012569AOS END CAP, ANTEGRADE FEMORAL NAIL 0mmS13242015-12-18
00848665012576AOS SCREW SPACER/COMPRESSION BOLT S13262015-12-18
00848665013832AOS SET SCREW, A/R S10852015-12-04
00848665016536AOS END CAP, TIBIAL NAIL 5mm1115-0502015-10-26
00848665016543AOS END CAP, TIBIAL NAIL 10mm1115-1002015-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
00840606186223ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03