FDA.report

Stratum Foot Plating System

Primary DI
00817701028505
Brand
Stratum Foot Plating System
Company
NEXTREMITY SOLUTIONS, INC.
Model
1MPJRVSMR
Device description
STRATUM 1st Metatarsophalangeal Joint (MPJ) Revision Plate Small - Right
Published
2021-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HRSPlate, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817701028505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817701028505008177010285058177010285050817701028505

GMDN Terms

TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterileA sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills.

Sterilization Methods

Method

Regulatory Flags

DUNS number
060783407
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810082893885Stealthfix Intraosseous Fixation SystemSF3515142022-08-04
00810082893892Stealthfix Intraosseous Fixation SystemSF3515162022-08-04
00810082893908Stealthfix Intraosseous Fixation SystemSF3515182022-08-04
00810082893915Stealthfix Intraosseous Fixation SystemSF3515202022-08-04
00810082893922Stealthfix Intraosseous Fixation SystemSF4515142022-08-04
00810082893939Stealthfix Intraosseous Fixation SystemSF4515162022-08-04
00810082893946Stealthfix Intraosseous Fixation SystemSF4515182022-08-04
00810082893953Stealthfix Intraosseous Fixation SystemSF4515202022-08-04
00810082893960Stealthfix Intraosseous Fixation SystemSF4515222022-08-04
00810082893977Stealthfix Intraosseous Fixation SystemSF4515242022-08-04
00810082893984Stealthfix Intraosseous Fixation SystemSF4515262022-08-04
00810082893991Stealthfix Intraosseous Fixation SystemSF4515282022-08-04
00810082894004Stealthfix Intraosseous Fixation SystemSF4515302022-08-04
00810082894011Stealthfix Intraosseous Fixation SystemSF4515322022-08-04
00810082894028Stealthfix Intraosseous Fixation SystemSF4520142022-08-04
00810082894035Stealthfix Intraosseous Fixation SystemSF4520162022-08-04
00810082894042Stealthfix Intraosseous Fixation SystemSF4520182022-08-04
00810082894059Stealthfix Intraosseous Fixation SystemSF4520202022-08-04
00810082894066Stealthfix Intraosseous Fixation SystemSF4520222022-08-04
00810082894073Stealthfix Intraosseous Fixation SystemSF4520242022-08-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00888118143266PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143273PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143280PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143297PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143303PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143310PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143327PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143334PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143341PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143358PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143365PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143372PURE PECTUSKLS-Martin L.P.HRS2026-03-23
10885862649690EquinoxeExactech, Inc.HRS2026-03-19
00841506141466Distal Elbow Plating SystemSKELETAL DYNAMICS L.L.C.HRS2026-03-05
05055662971552Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-03-04
05055662971569Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-03-04
08809986480521CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-03-04
00888867535053Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535077Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535091Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535114Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535138Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535152Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535176Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535190Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535213Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535237Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535251Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535275Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535299Arthrex®ARTHREX, INC.HRS2026-02-23