FDA.reportPublic FDA data

Medtronic Reusable Instruments

Primary DI
00885074150147
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
8367775
Device description
BONE SCREW 8367775 TREPHINE 7.5MM
Published
2022-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWJAWL
HWKTREPHINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWJAwlOrthopedic1
HWKTrephineOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885074150147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885074150147008850741501478850741501470885074150147

GMDN Terms#

Term, Definition table
TermDefinition
Bone trephineAn orthopaedic surgical blade designed to cut and remove circular sections of bone, typically for biopsy or percutaneous bone graft harvesting. It is typically a hollow cylinder with a circular, saw-like serrated working edge. It is an exchangeable device that may be attached to a manually-operated handle or to a powered rotary surgical handpiece. The device is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
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
00199150073504Medtronic Reusable InstrumentsEX12250012026-05-25
00199150071685Medtronic Reusable InstrumentsEX02261402026-05-24
00199150071692Medtronic Reusable InstrumentsEX02261502026-05-24
00199150071708Medtronic Reusable InstrumentsEX02261602026-05-24
00199150071715Medtronic Reusable InstrumentsEX02261702026-05-24
00199150071722Medtronic Reusable InstrumentsEX02261802026-05-24
00199150071739Medtronic Reusable InstrumentsEX02261902026-05-24
00199150071746Medtronic Reusable InstrumentsEX02262002026-05-24
00199150071753Medtronic Reusable InstrumentsEX02260402026-05-24
00199150071760Medtronic Reusable InstrumentsEX02260502026-05-24
00199150071777Medtronic Reusable InstrumentsEX02260602026-05-24
00199150071784Medtronic Reusable InstrumentsEX02260702026-05-24
00199150071791Medtronic Reusable InstrumentsEX02260802026-05-24
00199150071807Medtronic Reusable InstrumentsEX02260902026-05-24
00199150071814Medtronic Reusable InstrumentsEX02261002026-05-24
00199150072057Medtronic Reusable InstrumentsX65500232026-05-23
00199150072064Medtronic Reusable InstrumentsX65500242026-05-23
00199150072576Medtronic Reusable InstrumentsEX02260222026-05-23
00199150074532Medtronic Reusable InstrumentsX12250022026-05-22
00199150074549Medtronic Reusable InstrumentsX12250032026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
108101284636284.5mm Can. Full Thickness DrillT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWK2026-05-13
108101284636357.0mm Can. Full Thickness DrillT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWK2026-05-13
108101284636428.0mm Can. Full Thickness DrillT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWK2026-05-13
108101284636599.0mm Can. Full Thickness DrillT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWK2026-05-13
00190376706467InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706474InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706481InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706498InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706504InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706511InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706528InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706535InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706542InvictusALPHATEC SPINE, INC.HWK2026-04-09
07640375234773SCARLET AL-T INSTRUMENTATIONSpineArt SAHWJ2025-11-10
08059386744338Orthopaedic Surgical InstrumentsCITIEFFE SRLHWJ2025-11-06
00763000674410n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-26
09120129291507Awl, Curved, CannulatedI.T.S. GmbHHWJ2025-10-21
09120129291514Awl TrocarI.T.S. GmbHHWJ2025-10-21
00763000878245n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-20
00763000885243n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-11
B756STR00107SP0Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00108SP0Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00109SP0Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00110SP0Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00112SP0Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00113SP0Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00114SP0Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00115SP0Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00117SP0Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00118SP0Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21