FDA.reportPublic FDA data

Subtalar MBA Implant

Primary DI
00885556865859
Brand
Subtalar MBA Implant
Company
Smith & Nephew, Inc.
Model
050016
Catalog number
050016
Device description
GUIDE PIN INSERT HOLDER
Published
2023-01-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00885556865859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556865859008855568658598855568658590885556865859

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556833049Salto Talaris Total Ankle ProsthesisMJU547TMJU547T2022-12-22
00885556833339Salto Talaris Total Ankle ProsthesisMJU606TMJU606T2022-12-22
00885556855560Freedom Wrist Arthroplasty System3482153482152022-12-22
00885556917435Real IntelligenceROB20040ROB200402024-04-10
00885556780886REAL INTELLIGENCEROB10013SROB10013S2022-01-13
00885556757321REAL INTELLIGENCEROB10013ROB100132020-07-02
03596010411020VERSABOND71271140712711402015-08-29
03596010494726VERSABOND71271340712713402015-08-29
03596010507372VERSABOND71271440712714402015-09-28
03596010033246NA1100281100282015-08-25
03596010038852NA1114301114302015-08-25
03596010038890NA1114341114342015-08-25
03596010041968BUCK1124281124282015-08-25
03596010384591MIXOR71270041712700412015-08-29
03596010384607MIXOR71270042712700422015-08-29
03596010384638MIXOR71270051712700512015-08-29
03596010384645MIXOR71270052712700522015-08-29
03596010437617RENOVATION71369045713690452015-08-30
03596010472175MIXOR71270060712700602015-08-29
03596010515018VORTEX71272001712720012015-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437855MillenniumAvalign Technologies, Inc.LXH2026-11-04
00190776437862MillenniumAvalign Technologies, Inc.LXH2026-11-04
00190776439873MilleniumAvalign Technologies, Inc.LXH2026-11-04
00810155330057Tigon MedicalTigon Medical LLCLXH2026-11-04
08800308486030INNOVERSE SPINAL SYSTEMCG MedTech Co.,Ltd.LXH2026-11-04
09353903030331OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030348OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030379OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030386OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030393OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030416OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030430OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
00841731133564REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133571REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133601REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133618REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133625REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133632REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133649REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133656REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133670REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133687REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133700REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133731REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
07630699714822Surgical Manual InstrumentMedacta International SALXH2026-11-03
08800424704063VEGA Cervical Screw SystemGS Medical Co., Ltd.LXH2026-11-03
08809974815977Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.LXH2026-11-03
00810130207596MSIModern Surgical Instruments LLCLXH2026-11-02
07630894822506APTUSMedartis AGLXH2026-11-02
07630894822551APTUSMedartis AGLXH2026-11-02