PyroSphere CMC

Primary DI
00885556830840
Brand
PyroSphere CMC
Company
Smith & Nephew, Inc.
Model
TRL-435-10
Catalog number
TRL-435-10
Device description
PYROSPHERE TRIAL SZ. 10
Published
2022-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYIProsthesis, wrist, carpal trapezium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYIProsthesis, Wrist, Carpal TrapeziumOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042690000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042690000ASCENSION PYROSPHERE (PCS)Ascension Orthopedics, Inc.2004-11-13KYI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556830840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556830840008855568308408855568308400885556830840

GMDN Terms#

Term, Definition table
TermDefinition
Carpometacarpal interpositional spacer prosthesis trialA sterile copy of a final carpometacarpal interpositional spacer prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient, and to ensure its proper orientation and positioning. It is one of a set, or a set, of graduated sizes and is typically made of metal and/or polymer. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00: -

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010469182GENESIS II71421012714210122015-08-30
03596010469212GENESIS II71421015714210152015-08-30
03596010469229GENESIS II71421016714210162015-08-30
03596010469236GENESIS II71421017714210172015-08-30
03596010469267GENESIS II71421112714211122015-08-30
03596010469274GENESIS II71421113714211132015-08-30
03596010469281GENESIS II71421114714211142015-08-30
03596010469298GENESIS II71421115714211152015-08-30
03596010469304GENESIS II71421116714211162015-08-30
03596010469328GENESIS II71421118714211182015-08-30
03596010531018JOURNEY74024629740246292015-08-29
03596010531025JOURNEY74024632740246322015-08-29
03596010554468JOURNEY74024623740246232015-08-29
03596010554475JOURNEY74024626740246262015-08-29
03596010554512JOURNEY74024826740248262015-08-29
03596010554529JOURNEY74024829740248292015-08-29
03596010554536JOURNEY74024832740248322015-08-29
03596010000675OXINIUM71343603713436032015-08-30
03596010469199GENESIS II71421013714210132015-08-30
03596010469205GENESIS II71421014714210142015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810063560232Ensemble CMCEnsemble Orthopedics, Inc.KYI2025-05-06
M209177990THUMB MOD HEAD TITANIUM 13MM+2BIOPRO, INC.KYI2024-06-30
M209178000THUMB MOD HEAD TITANIIUM 12MMBIOPRO, INC.KYI2024-06-30
M209178010THUMB MOD HEAD TITANIUM 12MM+2BIOPRO, INC.KYI2024-06-30
M209178060THUMB MOD HEAD TITANIUM 14MMBIOPRO, INC.KYI2024-06-30
M209178070THUMB MOD HEAD TITANIUM 14MM+2BIOPRO, INC.KYI2024-06-30
M209178080THUMB MOD HEAD TITANIUM 15MMBIOPRO, INC.KYI2024-06-30
M209178090THUMB MOD HEAD TITANIUM 15MM+2BIOPRO, INC.KYI2024-06-30
M209177980THUMB MOD HEAD TITANIUM 13MMBIOPRO, INC.KYI2024-05-30
00810063560201Ensemble CMCEnsemble Orthopedics, Inc.KYI2023-08-01
00885556830789PyroSphere CMCSmith & Nephew, Inc.KYI2022-12-22
00885556830857PyroSphere CMCSmith & Nephew, Inc.KYI2022-12-22
00885556830864PyroSphere CMCSmith & Nephew, Inc.KYI2022-12-22
00885556830871PyroSphere CMCSmith & Nephew, Inc.KYI2022-12-22
00885556830888PyroSphere CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857748NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857755NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857762NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857779NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857786NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857793NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857809NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857816NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857823NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857915NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857922NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857939NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857946NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857953NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857960NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22