FDA.reportPublic FDA data

PRIME

Primary DI
M684P3SAQE581
Brand
PRIME
Company
Microport Orthopedics Inc.
Model
P3SAQE58
Catalog number
P3SAQE58
Device description
PRIME AM QUAD SHELL 58 MM GROUP E
Published
2021-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OQIHip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202705000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202705000Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc.2021-08-20OQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192629283602PrimaryGS10
M684P3SAQE581SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192629283602001926292836021926292836020192629283602

GMDN Terms#

Term, Definition table
TermDefinition
Metallic acetabulum prosthesisA sterile implantable principal component of a total hip prosthesis (acetabular component) designed to replace or repair the acetabulum. The component is of a one-piece construction and is made entirely of metal [e.g., stainless steel, titanium (Ti)]. Devices designed to assist implantation/fixation (e.g., screws, surgical guides, trial prosthesis, anatomical models) may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)872-0211Stephen.Weaver@ortho.microport.com

Regulatory Flags#

DUNS number
079118736
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192629298675ProphecyPNV08001PNV080012020-09-25
00192629298682ProphecyPNV08002PNV080022020-09-25
00192629298699ProphecyPNV08003PNV080032020-09-25
00192629298705ProphecyPNV08004PNV080042020-09-25
00192629298712ProphecyPNV08005PNV080052020-09-25
00192629298729ProphecyPNV08006PNV080062020-09-25
00192629298736ProphecyPNV08007PNV080072020-09-25
00192629298743ProphecyPNV08008PNV080082020-09-25
00192629298750ProphecyPNV08009PNV080092020-09-25
00192629298767ProphecyPNV08010PNV080102020-09-25
00192629298774ProphecyPNV08011PNV080112020-09-25
00192629298781ProphecyPNV08012PNV080122020-09-25
00192629298798ProphecyPNV08013PNV080132020-09-25
00192629298804ProphecyPNV08014PNV080142020-09-25
00192629298811ProphecyPNV08015PNV080152020-09-25
00192629298828ProphecyPNV08016PNV080162020-09-25
00192629298835ProphecyPNV08017PNV080172020-09-25
00192629298842ProphecyPNV08018PNV080182020-09-25
00192629298859ProphecyPNV08019PNV080192020-09-25
00192629298866ProphecyPNV08020PNV080202020-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982895006TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895167TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895174TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895181TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895198TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895204TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895211TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895228TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895235TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895242TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895266TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895273TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895280TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895297TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895303TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895310TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14