FDA.reportPublic FDA data

Ball Spike

Primary DI
00854226007066
Brand
Ball Spike
Company
STARR FRAME LLC
Model
SF-8800-5020
Catalog number
SF-8800-5020
Device description
Orthopedic manual surgical instrument
Published
2019-04-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00854226007066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854226007066008542260070668542260070660854226007066

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevatorA hand-held manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
804185838
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
00854226007004Starr Frame Half PinSF-2500-6101SF-2500-61012017-02-28
00854226007035Starr Frame Half PinSF-2250-5051SF-2250-50512017-02-28
00854226007127Starr Frame Half PinSF-2375-6071SF-2375-60712020-09-14
00854226007189Reinert Reduction Tool, 10.5mm, Low ProfileSF-8800-5017SF-8800-50172022-11-18
00854226007028Reinert Reduction Tool, 11mmSF-8800-5010SF-8800-50102019-04-05
00854226007059Reinert Reduction Tool, 10.5mmSF-8800-5015SF-8800-50152019-04-05
00854226007073HookSF-8800-5030SF-8800-50302019-04-05
00854226007080PaddleSF-8800-5040SF-8800-50402019-04-05
00854226007097Pry BarSF-8800-5050SF-8800-50502019-04-05
00854226007103Tommy BarSF-8800-5060SF-8800-50602019-04-05
00854226007110AL Quick ConnectorSF-8800-6010SF-8800-60102019-04-05
00854226007134Starr Frame Half PinSF-2375-6071SF-2375-60712020-09-14
00854226007011Starr Frame Half PinSF-2500-6101SF-2500-61012017-02-28
00854226007042Starr Frame Half PinSF-2250-5051SF-2250-50512017-02-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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