FDA.reportPublic FDA data

Anterior Hip Approach

Primary DI
00887868526435
Brand
Anterior Hip Approach
Company
Biomet Uk Ltd
Model
110039070
Catalog number
110039070
Published
2021-06-11
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
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
00887868526435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868526435008878685264358878685264350887868526435

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
219322575
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024683808Oxford® Partial Knee System5122111155122111152026-04-09
00889024683815Oxford® Partial Knee System5122111505122111502026-04-09
00889024683181Oxford® Partial Knee System1122111001122111002026-04-03
00889024683198Oxford® Partial Knee System1122112001122112002026-04-03
00889024683204Oxford® Partial Knee System1122113001122113002026-04-03
00889024683211Oxford® Partial Knee System1122114001122114002026-04-03
00889024683228Oxford® Partial Knee System1122115001122115002026-04-03
00889024683235Oxford® Partial Knee System1122116001122116002026-04-03
00889024683242Oxford® Partial Knee System1122117001122117002026-04-03
00889024683259Oxford® Partial Knee System1122211001122211002026-04-03
00889024683266Oxford® Partial Knee System1122212001122212002026-04-03
00889024683273Oxford® Partial Knee System1122213001122213002026-04-03
00889024683280Oxford® Partial Knee System1122214001122214002026-04-03
00889024683297Oxford® Partial Knee System1122215001122215002026-04-03
00889024683303Oxford® Partial Knee System1122216001122216002026-04-03
00889024683310Oxford® Partial Knee System1122217001122217002026-04-03
00889024683327Oxford® Partial Knee System1123111001123111002026-04-03
00889024683334Oxford® Partial Knee System1123112001123112002026-04-03
00889024683341Oxford® Partial Knee System1123113001123113002026-04-03
00889024683358Oxford® Partial Knee System1123114001123114002026-04-03

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Primary DI, Brand, Company table
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00196449035441Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
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00840311263882Streamline OCTXtant Medical Holdings, Inc.LXH2026-06-04
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