FDA.reportPublic FDA data

Stratum Ankle

Primary DI
00810082893618
Brand
Stratum Ankle
Company
Medartis Inc.
Model
SAJTSPRD
Device description
Stratum Ankle Joint Distractor
Published
2023-06-02
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
00810082893618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810082893618008100828936188100828936180810082893618

GMDN Terms#

Term, Definition table
TermDefinition
Osteotomy compression/distraction instrumentA non-sterile manual surgical instrument intended to be used for compression and distraction of an osteotomy. It is comprised of two arms that attach to pins/screws/nails inserted into both sides of the cut bone, and includes a mechanism (e.g., screw) used to close and open the arms of the device enabling compression and distraction at the osteotomy line. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
192756786
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
00810082892901Stratum AnkleSAPTTCSMLT2023-06-01
00810082891409Stratum AnkleSANLS3542S2023-05-31
00810082891454Stratum AnkleSANLS3552S2023-05-31
00810082891485Stratum AnkleSANLS3558S2023-05-31
00810082891508Stratum AnkleSANLS3562S2023-05-31
00810082891546Stratum AnkleSANLS3570S2023-05-31
00810082891584Stratum AnkleSANLS3516NS2023-05-31
00810082890341Stratum AnkleSALS3516NS2023-05-26
00810082890433Stratum AnkleSALS3534NS2023-05-26
00810082890778Stratum AnkleSALS5040S2023-05-26
00810082890846Stratum AnkleSALS5054S2023-05-26
00810082890921Stratum AnkleSALS5070S2023-05-26
00810082891010Stratum AnkleSALS5026NS2023-05-26
00810082891034Stratum AnkleSALS5030NS2023-05-26
00810082896817Stratum AnkleSANLS3580NS2023-05-26
00810082896848Stratum AnkleSANLS5076S2023-05-26
00810082896855Stratum AnkleSANLS5078S2023-05-26
00817701027553Stratum RSSTRM-NL-2412RS-ST2020-11-10
00817701027690Stratum RSSTRM-NL-2440RS-ST2020-11-10
00817701020059Nextra Hammertoe Correction SystemNX-3532K-SC2016-09-26

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Primary DI, Brand, Company table
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00888867550315Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550322Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550339Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550346Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550353Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550360Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550377Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550384Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552692Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552708Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552715Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552722Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552739Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552746Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552753Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552760Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574564Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574571Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574588Arthrex®ARTHREX, INC.LXH2026-09-18
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04054896000893(Re-) Positioning ToolsSilony Medical GmbHLXH2026-09-18
04054896000909(Re-) Positioning ToolsSilony Medical GmbHLXH2026-09-18
04054896000916(Re-) Positioning ToolsSilony Medical GmbHLXH2026-09-18
04054896000923AdapterSilony Medical GmbHLXH2026-09-18