FDA.reportPublic FDA data

Acetabular Component Forceps

Primary DI
00847538001396
Brand
Acetabular Component Forceps
Company
SYMMETRY MEDICAL INC.
Model
14-001-000
Catalog number
2709-02-008;00-9986-020-21;430020
Device description
Acetabular Component Forceps
Published
2022-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00847538001396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847538001396008475380013968475380013960847538001396

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079881212
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
00847538007787Component Impactor10-016-400-15002011-03-0372022-05-17
00847538005479Patella Caliper802-01-1122025-12-10
00847538007930Bone Hook - Small10-257-000803-61-0252025-10-20
00847538008654HP Extraction Standard Removal Case87-10082011-03-0482023-11-28
00847538015256Flexible Osteotome System with Radel Case30-005-0002709-04-000; 30-005-000-15002023-07-17
00847538019179Femoral Tray30-037-4002709-01-000; 30-037-400-15002023-07-17
00817766026423GLOBAL UNITE™ Short Stem Instrumentation2236002112021-09-01
00847538010558Tuning Fork12-070-0002011-03-0302022-05-17
00847538010565MBT Tray/Sleeve Separator12-071-4002011-03-0532022-05-17
00847538010572Sleeve Removal Tool12-072-0002011-03-0312022-05-17
00847538005431Extraction Screw, 8 MM12-010-000-15002011-03-0422022-05-13
00847538010527Head Extractor12-063-0002500-00-7792022-05-13
00847538010534Forked Stem Extractor Wide12-065-0002500-00-7812022-05-13
00847538010541Forked Stem Extractor Narrow12-067-0002500-00-7802022-05-13
00847538015751Adapter Slaphammer to Locking Pliers12-053-000-15002011-03-0462022-05-13
00847538015768Stem Trial Remover Slaphammer adapter12-054-000-15002011-03-0472022-05-13
00847538015775Tibial Component Extractor74-591-000-15002011-03-0452022-05-13
00847538007916Head Removal Fork10-246-4002500-00-7762022-05-12
00847538001471T-Bar Stem Extractor10-062-0002709-05-003;00-9986-040-122022-05-11
00847538010473Driver Shaft w/Slaphammer w/Hudson Connector12-048-0002709-05-0012022-05-11

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Primary DI, Brand, Company table
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M7401001380OptiLIF Endo, Direct Visualization SystemSPINEOLOGY INC.LXH2026-10-01
00840606191425PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191432PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191449PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191456PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00810017915668SABER-XA, Trial InserterELEVATION SPINE, INC.LXH2026-09-29
00810017916030SABER-XA Straight Awl, Self-GuidedELEVATION SPINE, INC.LXH2026-09-29
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00810055525331Onyx 7.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525348Onyx 4.5MM Awl Tip TapSi-Bone Inc.LXH2026-09-29
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00810055525386Onyx Feeler ProbeSi-Bone Inc.LXH2026-09-29
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00810055525409Onyx Curved ProbeSi-Bone Inc.LXH2026-09-29
00810055525416Onyx 8.25mm TrephineSi-Bone Inc.LXH2026-09-29
00810055525423Onyx Threaded Removal DriverSi-Bone Inc.LXH2026-09-29
00810055525430Onyx 5.5 & 6.5mm OsteotomeSi-Bone Inc.LXH2026-09-29
00810055525447Onyx 7.5mm OsteotomeSi-Bone Inc.LXH2026-09-29
00810055525454Onyx Counter Torque, ShortSi-Bone Inc.LXH2026-09-29
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00810055525478Onyx Counter Torque, LongSi-Bone Inc.LXH2026-09-29
00810055525485Onyx Head TurnerSi-Bone Inc.LXH2026-09-29