FDA.report

DJO SURGICAL

Primary DI
00190446689720
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
803-15-101
Device description
EMPOWR Acet DM, Liner Impactor Extension, Straight
Published
2022-08-19
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

Related Records

Product Codes

CodeName
HWAIMPACTOR

Product Code Classifications

CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190446689720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446689720001904466897201904466897200190446689720

GMDN Terms

TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
154074504
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 DIBrandModelCatalogPublished
00190446905998DJO SURGICAL800-05-2142026-03-03
00190446960515DJO SURGICALS-2019612026-02-17
00190446905950DJO SURGICAL800-05-2102026-02-11
00190446905974DJO SURGICAL800-05-2112026-02-11
00190446906087DJO SURGICAL800-99-1672026-02-11
00190446906117DJO SURGICAL801-05-2122026-02-11
00190446924470DJO SURGICALS-2019282025-10-10
00190446946007DJO SURGICALS-2019562025-12-11
00190446893332DJO SURGICAL941-01-32B2025-12-04
00190446893349DJO SURGICAL941-01-36D2025-12-04
00190446893356DJO SURGICAL941-01-40F2025-12-04
00190446893363DJO SURGICAL941-01-44H2025-12-04
00190446893370DJO SURGICAL942-01-32B2025-12-04
00190446893387DJO SURGICAL942-01-36D2025-12-04
00190446893394DJO SURGICAL942-01-40F2025-12-04
00190446893400DJO SURGICAL942-01-44H2025-12-04
00190446893417DJO SURGICAL943-01-32B2025-12-04
00190446893424DJO SURGICAL943-01-36D2025-12-04
00190446893431DJO SURGICAL943-01-40F2025-12-04
00190446893448DJO SURGICAL943-01-44H2025-12-04

Other Devices Sharing Product Codes

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00840277133403Innomed, Inc.INNOMED, INC.HWA2026-03-11
00810123209934Adler Instrument CompanyAdler, Inc.HWA2026-03-03
05056405508578Charnley Femoral Prosthesis PusherPLATTS & NISBETT LIMITEDHWA2026-02-11
00822409133178N/AOrtho Development CorporationHWA2026-02-05
00822409133185N/AOrtho Development CorporationHWA2026-02-05
00822409133192N/AOrtho Development CorporationHWA2026-02-05
00822409133215N/AOrtho Development CorporationHWA2026-02-05
10603295554974EMPHASYSDEPUY ORTHOPAEDICS, INC.HWA2026-02-04
04026575048168General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2026-02-02
04026575080182General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2026-02-02
08800017299358BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373887734BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373887826BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373887833BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373888021BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373888045BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
09421028112536Enztec Classic OCI - Trinket 5/16-24 UNF-02ENZTEC LIMITEDHWA2026-01-12
09421028113540Enztec Classic OCI - Trinket 3/8-16 UNC-01ENZTEC LIMITEDHWA2026-01-12
09421028113557Enztec Classic OCI - Trinket 5/16-24 UNF-01ENZTEC LIMITEDHWA2026-01-12
09421028113571Enztec Classic OCI - Trinket 3/8-24 UNF-01ENZTEC LIMITEDHWA2026-01-12
04026575448500General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2025-11-07
04026575448517General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2025-11-07
04026575448524General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2025-11-07
09421038410516 ATTUNE FEMORAL IMPACTORENZTEC LIMITEDHWA2025-10-21
09421038410523ATTUNE FEMORAL IMPACTOR HEADENZTEC LIMITEDHWA2025-10-21
00190446924470DJO SURGICALEncore Medical, L.P.HWA2025-10-10
09309000394289MAC SurgicalMAC SURGICAL PTY LTDHWA2025-09-30
09309000394296MAC SurgicalMAC SURGICAL PTY LTDHWA2025-09-30