FDA.reportPublic FDA data

Medacta Broach Handle

Primary DI
00854515008293
Brand
Medacta Broach Handle
Company
Unique Surgical
Model
Left, Zimmer Style
Catalog number
01.10.10.461
Published
2023-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00854515008293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854515008293008545150082938545150082930854515008293

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system, single-useA sterile, frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
818-813-8527info@UniqueSurgical.com

Regulatory Flags#

DUNS number
079820535
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
00850080482063Drill BitBayonet Drill Bit Ø3.2 L152026-01-30
00850080482070Drill BitBayonet Drill Bit Ø3.2 L202026-01-30
00850080482087Drill BitBayonet Drill Bit Ø3.2 L252026-01-30
00850080482094Drill BitBayonet Drill Bit Ø3.2 L302026-01-30
00850080482100Drill BitBayonet Drill Bit Ø3.2 L352026-01-30
00850080482117Drill BitBayonet Drill Bit Ø3.2 L402026-01-30
00850080482124Drill BitBayonet Drill Bit Ø3.2 L452026-01-30
00850080482131Drill BitBayonet Drill Bit Ø3.2 L502026-01-30
00850080482148Drill BitBayonet Drill Bit Ø3.2 L552026-01-30
00850080482155Drill BitBayonet Drill Bit Ø3.2 L602026-01-30
00850080482162Drill BitBayonet Drill Bit Ø3.2 L652026-01-30
00850080482179Drill BitBayonet Drill Bit Ø3.2 L702026-01-30
00850080482186Drill BitBayonet Drill Bit Ø3.2 L752026-01-30
00850080482193Drill BitBayonet Drill Bit Ø3.2 L802026-01-30
00854515008002ImpactorFemoral2023-01-06
00854515008989Medacta Glenosphere Impactor TipCannulated2025-09-16
00854515008927ScrewdriverU-Joint, 3.5mm Hex, Hudson Connector2025-08-07
00854515008934ScrewdriverSolid Shaft, 3.5mm Hex, Hudson Connector2025-08-07
00850080482025Screw ForcepsMedacta, with Cap2025-12-18
00850080482032Bone PinMedacta, Fluted2025-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810141040892Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040908Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040915Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040953Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040977Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141047532Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141047549Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00840314270351gSourceGSOURCE LLCLXH2026-10-22
00840606175234PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606185820PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186506LateralSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186513LateralSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186575SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186612SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186643SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186674SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186704SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186735SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186810SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187091ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187121PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187640OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00840606189934OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00840606189941OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00190776436766MillenniumAvalign Technologies, Inc.LXH2026-10-21
07630699705240Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705257Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705264Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705271Surgical Manual InstrumentMedacta International SALXH2026-10-21
10840642132786Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-21