FDA.reportPublic FDA data

EXPert Nail

Primary DI
H67904003002S0
Brand
EXPert Nail
Company
SYNTHES (U.S.A.) LP
Model
04.003.002S
Catalog number
04003002S
Device description
12MM TI END CAP T40 STARDRIVE 10MM EXT-STER/FEMORAL NAILS-EX
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033618000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033618000SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEMSynthes (Usa)2004-02-05HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982081346PrimaryGS10
H67904003002S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698208134610886982081346

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail end-capA small, rounded plug, cover or threaded screw designed to seal the proximal end of an orthopaedic nail implanted to treat a damaged bone (e.g., a fracture), to prevent healing tissue from growing into the hollow nail and to facilitate nail extraction. It is typically made of metal [e.g., high-grade stainless steel, titanium (Ti)], and is available in a variety of sizes. It may also be used to securely lock the most proximal oblique locking screw or help extend the length of a nail when necessary. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
832637081
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
false
Expiration date on label
true
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
10886982249210NA60.550.040605500402017-02-20
10886982239884NA530.4125304122016-12-31
10886982192172NA329.7223297222017-02-20
10886982192295LC-DCP329.9183299182017-02-20
10886982201461NA398.56398562017-02-20
10886982201478NA398.58398582017-02-20
10705034718040NA03.620.219036202192018-10-29
10705034767802VentroFix304.8323048322016-12-31
10705034775418NA389.2963892962016-12-31
10705034775425NA389.2973892972016-12-31
10705034775432NA389.2983892982016-12-31
10705034775449NA389.2993892992016-12-31
10705034798455NA690.0386900382016-12-31
10887587039893NA338.7613387612016-12-31
10886982338778MAXFRAME1100022-011100022012024-02-05
10886982338570MAXFRAME1100011-011100011012022-04-26
10886982338587MAXFRAME1100010-011100010012022-04-26
10886982338594MAXFRAME1100012-011100012012022-04-26
10886982338600MAXFRAME1100007-011100007012022-04-26
10886982237217NA510.1615101612019-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09353903016311NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2026-04-13
09353903016328NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2026-04-13
03700569604233NANEWCLIP TECHNICSHWC2024-11-15
03700569604257NANEWCLIP TECHNICSHWC2024-11-15
03700569604271NANEWCLIP TECHNICSHWC2024-11-15
03700569604295NANEWCLIP TECHNICSHWC2024-11-15
03700569604318NANEWCLIP TECHNICSHWC2024-11-15
03700569604332NANEWCLIP TECHNICSHWC2024-11-15
03700569604356NANEWCLIP TECHNICSHWC2024-11-15
03700569604370NANEWCLIP TECHNICSHWC2024-11-15
03700569633936NANEWCLIP TECHNICSHWC2024-11-15
03700569633950NANEWCLIP TECHNICSHWC2024-11-15
03700569633974NANEWCLIP TECHNICSHWC2024-11-15
03700569633998NANEWCLIP TECHNICSHWC2024-11-15
03700569634018NANEWCLIP TECHNICSHWC2024-11-15
03700569634032NANEWCLIP TECHNICSHWC2024-11-15
03700569634056NANEWCLIP TECHNICSHWC2024-11-15
09353903015376NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015383NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015390NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015406NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015413NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015420NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015437NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015444NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015451NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015468NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015475NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015482NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015499NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16