MBF

Product Code: MBF


Products Classified as MBF

4615Prosthesis, Shoulder, Semi-constrained, Metal/polymer, UncementedShoulder Joint Metal/polymer/metal Nonconstrained Or Semi-constrained Porous-coated Uncemented Prosthesis.

Total Product Life Cycle (TPLC) Devices

4615Prosthesis, Shoulder, Semi-constrained, Metal/polymer, UncementedShoulder Joint Metal/polymer/metal Nonconstrained Or Semi-constrained Porous-coated Uncemented Prosthesis.

FDA Consensus Standards

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented [34059]21 CFR §888.3670 🔎
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented [38231]21 CFR §888.3670 🔎
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented [37410]21 CFR §888.3670 🔎
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented [37411]21 CFR §888.3670 🔎
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented [37435]21 CFR §888.3670 🔎
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented [35610]21 CFR §888.3670 🔎
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented [37433]21 CFR §888.3670 🔎
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented [37816]21 CFR §888.3670 🔎
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented [33508]21 CFR §888.3670 🔎
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented [37831]21 CFR §888.3670 🔎
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented [32210]21 CFR §888.3670 🔎
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented [37814]21 CFR §888.3670 🔎

Pre-market Notifications for MBF

K222427PRIMA TT GlenoidLimaCorporate S.p.A.
K220792SMR Reverse LinerLimaCorporate S.p.A.
K213856Identity Shoulder SystemZimmer Inc.
K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC
K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics LLC
K201905SMR 140° Reverse Humeral BodyLimaCorporate S.p.A.
K193038Comprehensive Shoulder SystemBiomet Manufacturing Corp.
K191963SMR Finned Short StemsLimaCorporate S.p.A
K183553Compress And Mini Compress Anti-Rotation SpindlesBiomet, Inc
K173824Humeral Short Stem SystemShoulder Innovations Inc
K163397SMR Hybrid Glenoid SystemLimacorporate S.p.A.
K162068ARROW Anatomical Porous GlenoidFournitures Hospitalieres Industrie
K140390TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESISBIOMET MANUFACTURING CORP.
K130126SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEMBIOMET, INC.
K123297COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEMBIOMET MANUFACTUTING CORP.

Global Unique Device Identification Database

00880304993259PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
00880304850385PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
00880304850378PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
00880304850309PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
00880304848870Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
00880304848863Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
00880304811287PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
00880304811263PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
00880304811133PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
00880304806108PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
00880304806085PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
00880304806054PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
00880304714823PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
00880304714793PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
00880304714786PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Maude Adverse Events

GLOBAL ADVANTAGE PC STEM 10MMDEPUY ORTHOPAEDICS INC US2020-03-10
COMPREHENSIVE PRIMARY STEMZIMMER BIOMET, INC.2020-02-20
COMPREHENSIVE MINI PRIMARY STEMZIMMER BIOMET, INC.2020-01-06
COMP PRIMARY STEM 6MM MINIZIMMER BIOMET, INC.2019-11-11
UNK - EPOCAOBERDORF SYNTHES PRODUKTIONS GMBH2019-10-31
VERSA-DIAL/COMP TI STD TAPERZIMMER BIOMET, INC.2019-10-14
COMPR NANO HMRL PPS 32MMZIMMER BIOMET, INC.2019-09-11
COMP PRIMARY STEM 11MM MINIZIMMER BIOMET, INC.2019-08-13
COMP LK SCR 3.5HEX 4.75X35 STZIMMER BIOMET, INC.2019-08-09
COMP LK SCR 3.5HEX 4.75X20 STZIMMER BIOMET, INC.2019-08-09
COMP LK SCR 3.5HEX 4.75X30 STZIMMER BIOMET, INC.2019-08-09
COMP PRIMARY STEM 13MM MINIZIMMER BIOMET, INC.2019-08-09
COMP LK SCR 3.5HEX 4.75X15 STZIMMER BIOMET, INC.2019-08-09
COMP PRIMARY STEM 13MM STDZIMMER BIOMET, INC.2019-08-05
COMPRESS HA ANTI-ROTATION SPINDLEZIMMER BIOMET, INC.2019-07-24
VERSA-DIAL/COMP TI STD TAPERZIMMER BIOMET, INC.2019-07-22
VERSA-DIAL/COMP TI STD TAPERZIMMER BIOMET, INC.2019-07-18
VERSA-DIAL/COMP TI STD TAPERZIMMER BIOMET, INC.2019-07-03
COMPR SRS 50MM DST HUM BDY RTZIMMER BIOMET, INC.2019-05-31
VERSA-DIAL 42X18X46 HUM HEADZIMMER BIOMET, INC.2019-05-31
COMPREHENSIVE STANDARD TAPER ADAPTORZIMMER BIOMET, INC.2019-05-31
COMPR SRS 50MM DST HML BDY LTZIMMER BIOMET, INC.2019-05-28
COMP PRIMARY STEM 8MM STDZIMMER BIOMET, INC.2019-05-02
GLOBAL UNITE STD STEM SZ 6DEPUY IRELAND 96166712019-05-02
COMP PRIMARY STEM 13MM MINIZIMMER BIOMET, INC.2019-05-01
VERSA-DIAL/COMP TI STD TAPERZIMMER BIOMET, INC.2019-05-01
COMP LOCKING SCREW 4.75X15MMZIMMER BIOMET, INC.2019-05-01
COMP RVS CNTRL SCR 6.5X35MM STZIMMER BIOMET, INC.2019-05-01
VERSA-DIAL/COMP TI STD TAPERZIMMER BIOMET, INC.2019-04-11
VERSA-DIAL 42X18X46 HUM HEADZIMMER BIOMET, INC.2019-04-04
VERSA-DIAL/COMP TI STD TAPERZIMMER BIOMET, INC.2019-04-04
COMP PRIMARY STEM 12MM STDZIMMER BIOMET, INC.2019-04-03
VERSA-DIAL/COMP TI STD TAPERZIMMER BIOMET, INC.2019-04-03
VERSA-DIAL 46X21X50 HUM HEADZIMMER BIOMET, INC.2019-04-03
VERSA-DIAL/COMP TI STD TAPERZIMMER BIOMET, INC.2019-04-03
VERSA-DIAL 46X21X50 HUM HEADZIMMER BIOMET, INC.2019-04-03
COMP PRIMARY STEM 11MM MINIZIMMER BIOMET, INC.2019-04-03
COMPR 12MM IM HMRLZIMMER BIOMET, INC.2019-04-01
COMP PRIMARY STEM 8MM STDZIMMER BIOMET, INC.2019-03-14
VERSA-DIAL/COMP TI STD TAPERZIMMER BIOMET, INC.2019-03-14
COMP PRIMARY STEMZIMMER BIOMET, INC.2019-03-13
VERSA-DIAL/COMP TI STD TAPERZIMMER BIOMET, INC.2019-03-06
VERSA-DIAL 42X18X46 HUM HEADZIMMER BIOMET, INC.2019-03-06
COMP PRIMARY STEM 7MM MINIZIMMER BIOMET, INC.2019-03-01
VERSA-DIAL/COMP TI STD TAPERZIMMER BIOMET, INC.2019-03-01
COMP PRIMARY STEM 12MM STDZIMMER BIOMET, INC.2019-01-15
VERSA-DIAL/COMP TI STD TAPERZIMMER BIOMET, INC.2019-01-10
COMP PRIMARY STEM 14MM MINIZIMMER BIOMET, INC.2019-01-07
VERSA-DIAL 50X21X57 HUM HEADZIMMER BIOMET, INC.2018-12-21
COMP PRIMARY BROACH/PROV 16MMZIMMER BIOMET, INC.2018-12-18

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