FDA.reportPublic FDA data

Wheelhouse Medical Specials

Primary DI
00850058050287
Brand
Wheelhouse Medical Specials
Company
Wheelhouse Medical
Model
WM01-0157
Published
2025-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00850058050287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850058050287008500580502878500580502870850058050287

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic graft inserter, reusableA hand-held manual surgical instrument designed to push a cartilage or bone graft into a position from which the graft can be delivered into a chondral defect [e.g., during anterior cruciate ligament (ACL) reconstruction surgery]. This device is available in a variety of designs, such as a plunger made of high-grade materials [e.g., stainless steel or titanium (Ti)] used to advance the graft down its tubular-shaped holder or possibly a bone graft funnel and into place; it is also available in a variety of sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
7049629429johnsouza@wheelhouse-medical.com

Regulatory Flags#

DUNS number
118496839
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
00850058050270Wheelhouse Medical SpecialsWM01-01742026-07-28
00850058050294Wheelhouse Medical SpecialsWM01-01752026-07-28
00850058050300Wheelhouse Medical SpecialsWM01-01762026-07-28
00850058050317Wheelhouse Medical SpecialsWM01-01852026-07-28
00850058050324Wheelhouse Medical SpecialsWM01-01912026-07-28
00850058050331Wheelhouse Medical SpecialsWM01-01892026-07-28
00850058050348Wheelhouse Medical SpecialsWM01-01902026-07-28
00850058050355Wheelhouse Medical SpecialsWM01-01882026-07-28
00850058050157Wheelhouse Medical SpecialsWM01-01412025-10-08
00850058050164Wheelhouse Medical SpecialsWM01-01422025-10-08
00850058050188Wheelhouse Medical SpecialsWM01-01442025-10-08
00850058050225Wheelhouse Medical SpecialsWM01-01482025-10-08
00850058050256Wheelhouse Medical SpecialsWM01-01532025-10-08
00850058050263Wheelhouse Medical SpecialsWM01-01732025-10-08
00850058050003Wheelhouse Medical SpecialsWM01-0072-0102024-10-23
00850058050010Wheelhouse Medical SpecialsWM01-0072-0112024-10-23
00850058050027Wheelhouse Medical SpecialsWM01-0072-0122024-10-23
00850058050034Wheelhouse Medical SpecialsWM01-0072-0132024-10-23
00850058050041Wheelhouse Medical SpecialsWM01-0072-0142024-10-23
00850058050058Wheelhouse Medical SpecialsWM01-0072-0152024-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150083473Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-08-03
B382SD480033220Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD480090Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
00190776407391MillenniumAvalign Technologies, Inc.LXH2026-07-31
00840606191579Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191630Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191647Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191678Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191685Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191692Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191708Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191722Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191739Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191777Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191920Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191937Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191968Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
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00888867544833Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544840Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544857Arthrex®ARTHREX, INC.LXH2026-07-31