Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008021110

FEI Number

3008021110

Entity Name

Limacorporate S.p.A.

City/State/Country

Villanova di San Daniele Udine, IT

Establishment Address

Via Nazionale 52, Villanova di San Daniele Udine 33038, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Limacorporate S.p.A. (Owner Number: 10032506)

Owner / Operator Contact Address

Via Nazionale 52, Villanova di San Daniele, IT-UD 33038, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201084

PMA Number

N/A

All Registered Proprietary Names

Plier Bone screws 5mm H-MAX S stem SMR TT Metal Back Glenoid SMR Lateralized connectors with screws H-MAX S Femoral Hip System Drill Bit Guide Delta TT Jumbo Cups SMR Shoulder System SMR TT Augmented Glenoid System Physica KR knee system SMR Modular Glenoid PRIMA TT Glenoid Removal Plier SMR TT Augmented Glenoid System Physica system Delta Multihole TT Pro Acetabular System TEMA Elbow system SMR Shoulder System Delta Dual Mobility System Helix drill CMD 26-1040 ProMade Shoulder CMD 25-1480 ProMade Shoulder CMD 25-1165 ProMade Shoulder CMD 25-1450 ProMade Shoulder CMD 25-1111 ProMade Shoulder CMD 25-1411 ProMade Shoulder CMD 25-1607 ProMade Shoulder CMD 24-1620 ProMade Shoulder CMD 26-1013 ProMade Shoulder CMD 25-1448 ProMade Shoulder CMD 25-1151 ProMade Shoulder CMD 25-1223 ProMade Shoulder CMD 25-1444 ProMade Shoulder CMD 25-1559 ProMade Shoulder CMD 25-1248 ProMade Shoulder CMD 25-1708 ProMade Shoulder CMD 25-1087 ProMade Shoulder CMD 25-1303 ProMade Shoulder CMD 25-1481 ProMade Shoulder CMD 26-1048 ProMade Shoulder CMD 26-1099 ProMade Shoulder CMD 24-1132 Promade Shoulder CMD 24-1380 ProMade Shoulder CMD 24-1410 ProMade Shoulder CMD 24-1375 ProMade Shoulder CMD 24-1470 ProMade Shoulder CMD 24-1347 ProMade Shoulder CMD 24-1456 ProMade Shoulder CMD 24-1446 ProMade Shoulder CMD 24-1509 ProMade Shoulder CMD 24-1486 ProMade Shoulder CMD 25-1176 ProMade Shoulder CMD 24-1422 ProMade Shoulder CMD 25-1024 ProMade Shoulder CMD 25-1253 ProMade Shoulder CMD 24-1629 ProMade Shoulder CMD 24-1592 ProMade Shoulder CMD 25-1136 ProMade Shoulder CMD 24-1457 ProMade Shoulder CMD 25-1233 ProMade Shoulder CMD 24-1616 ProMade Shoulder CMD 25-1637 ProMade Shoulder CMD 24-1429 ProMade Shoulder CMD 24-1556 ProMade Shoulder CMD 25-1357 ProMade Shoulder CMD 25-1110 ProMade Shoulder CMD 24-1240 ProMade Shoulder CMD 25-1631 ProMade Shoulder CMD 25-1675 ProMade Shoulder CMD 24-1365 ProMade Shoulder CMD 25-1704 ProMade Shoulder CMD 25-1603 ProMade Shoulder CMD 25-1369 ProMade Shoulder CMD 25-1395 ProMade Shoulder CMD 25-1568 ProMade Shoulder CMD 24-1224 ProMade Shoulder CMD 26-1036 ProMade Shoulder CMD 25-1549 ProMade Shoulder CMD 24-1481 ProMade Shoulder CMD 24-1263 ProMade Shoulder CMD 25-1071 ProMade Shoulder CMD 25-1770 ProMade Shoulder CMD 25-1724 ProMade Shoulder CMD 25-1642 ProMade Shoulder CMD 25-1794 ProMade Shoulder CMD 24-1362 ProMade Shoulder CMD 26-1169 ProMade Shoulder CMD 24-1327 ProMade Shoulder CMD 25-1596 ProMade Shoulder CMD 25-1785 ProMade Shoulder CMD 25-1652 ProMade Shoulder CMD 25-1038 ProMade Shoulder CMD 25-1336 ProMade Shoulder CMD 26-1086 ProMade Shoulder CMD 25-1610 ProMade Shoulder CMD 25-1164 ProMade Shoulder CMD 26-1065 ProMade Shoulder CMD 25-1611 ProMade Shoulder CMD 25-1217 ProMade Shoulder CMD 25-1752 ProMade Shoulder CMD 26-1020 ProMade Shoulder CMD 25-1464 ProMade Shoulder CMD 24-1423 ProMade Shoulder CMD 25-1274 ProMade Shoulder CMD 25-1079 ProMade Shoulder CMD 25-1466 ProMade Shoulder CMD 24-1542 ProMade Shoulder CMD 25-1356 ProMade Shoulder CMD 25-1042 ProMade Shoulder AMF TT Cones Delta TT Pro CMD 25-1689 ProMade Hip CMD 25-1131 ProMade Hip ArTT Locking Bone Screws Revision Bone Screws Bone Screws Revision Femoral Stem Revision Femoral Head PRIMA Glenoid System SMR Shoulder System PRIMA Humeral System SMR Resurfacing SMR Reverse Liner AMF TT Cones MINIMA S System PRIMA Humeral System Delta Multihole TT Pro Acetabular System CMD 24-1137 ProMade Hip CMD 24-1336 ProMade Hip CMD 24-1298 ProMade Hip CMD 24-1441 ProMade Hip CMD 24-1586 ProMade Hip CMD 24-1278 ProMade Hip CMD 24-1568 ProMade Hip CMD 24-1491 ProMade Hip CMD 24-1434 ProMade Hip CMD 24-1454 ProMade Hip CMD 24-1494 ProMade Hip CMD 24-1439 Promade Hip CMD 24-1396 ProMade Hip CMD 24-1417 ProMade Hip Physica PS Knee System SMR Shoulder System C2 Femoral Stem Powered motor accessory/attachment SMR Shoulder System SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid Reamers CMD 25-1728 ProMade Elbow CMD 25-1651 ProMade Elbow CMD 24-1623 ProMade Elbow CMD 24-1416 ProMade Elbow CMD 24-1029 ProMade Elbow CMD 24-1503 ProMade Elbow CMD 23-1428 ProMade Elbow CMD 25-1142 ProMade Elbow CMD 25-1324 ProMade Elbow CMD 25-1409 ProMade Elbow CMD 25-1128 ProMade Elbow CMD 25-1245 ProMade Elbow CMD 25-1076 ProMade Elbow CMD 25-1406 ProMade Elbow CMD 24-1613 ProMade Elbow CMD 26-1045 ProMade Ebow CMD 24-1186 ProMade Elbow CMD 24-1313 ProMade Elbow CMD 24-1059 ProMade Elbow CMD 25-1082 ProMade Elbow CMD 26-1142 ProMade Elbow CMD 24-1157 ProMade Elbow CMD 25-1115 ProMade Elbow CMD 25-1264 ProMade Elbow CMD 25-1242 ProMade Elbow CMD 24-1524 ProMade Elbow CMD 25-1547 ProMade Elbow CMD 26-1188 ProMade Elbow Dynamometer, Nonpowered CTA heads adaptor for reverse humeral body SMR Reverse Shoulder System Physica LMC knee system TREPHINE SMR Hybrid Glenoid System CMD 24-1393 ProMade Hip wrench EXTRACTOR CMD 25-1521 ProMade Hip CMD 24-1610 ProMade Hip CMD 25-1313 ProMade Hip CMD 25-1734 ProMade Hip CMD 26-1133 ProMade Hip CMD 25-1758 ProMade Hip CMD 25-1131 ProMade Hip CMD 25-1083 ProMade Hip CMD 25-1290 ProMade Hip CMD 26-1196 ProMade Hip CMD 25-1419 ProMade Hip CMD 25-1691 ProMade Hip CMD 25-1793 ProMade Hip CMD 26-1107 ProMade Hip CMD 25-1586 ProMade Hip CMD 25-1622 ProMade Hip CMD 26-1091 ProMade Hip CMD 25-1738 ProMade Hip CMD 26-1019 ProMade Hip CMD 26-1106 ProMade Hip CMD 24-1641 ProMade Hip CMD 25-1587 ProMade Hip CMD 25-1075 ProMade Hip CMD 25-1668 ProMade Hip CMD 25-1568 ProMade Hip CMD 25-1416 ProMade Hip CMD 25-1081 ProMade Hip CMD 25-1617 ProMade Hip CMD 25-1137 ProMade Hip CMD 25-1743 ProMade Hip CMD 24-1603 ProMade Hip CMD 25-1735 ProMade Hip CMD 26-1053 ProMade Hip CMD 25-1271 ProMade Hip CMD 26-1098 ProMade Hip CMD 25-1402 ProMade Hip CMD 25-1725 ProMade Hip CMD 25-1489 ProMade Hip CMD 25-1362 ProMade Hip CMD 25-1446 ProMade Hip CMD 25-1053 ProMade Hip CMD 25-1685 ProMade Hip CMD 25-1624 ProMade Hip CMD 25-1681 ProMade Hip CMD 26-1138 ProMade Hip CMD 25-1228 ProMade Hip CMD 24-1584 ProMade Hip CMD 25-1207 ProMade Hip CMD 25-1238 ProMade Hip SMR 40mm Glenosphere Physica system Revision Femoral Stem Trial Screwdriver SMR 3-Pegs Glenoids SMR Finned Short Stems Awl Master SL Femoral Stem Physica system LimaCorporate Kirschner wire SMR Shoulder System Physica system

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2011-12-21
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-07-27
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2021-07-27
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2021-07-27
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2021-07-27
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2016-08-23
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2016-08-23
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2016-08-23
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2014-06-05
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2014-06-05
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2014-06-05
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-02-05
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2019-02-05
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2019-02-05
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2019-02-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2016-12-12
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2016-12-12
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2016-12-12
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2016-12-12
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2025-09-01
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2014-07-02
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2014-07-02
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2014-07-02
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2014-07-02
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2011-12-21
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2011-12-21
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2019-11-26
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2019-11-26
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2019-11-26
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-11-26
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2015-05-07
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-05-07
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2015-06-08
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2015-06-08
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2022-12-05
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2022-12-05
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2024-07-26
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2020-11-20
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2020-11-20
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2020-11-20
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-11-20
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2025-07-24
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2020-07-15
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2020-07-15
JDB	Prosthesis, Elbow, Semi-Constrained, Cemented	Orthopedic	Class 2	888.3160	2023-02-03
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2023-02-03
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2011-12-21
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2011-12-21
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-05-27
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2019-05-27
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2019-05-27
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2013-11-20
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-06-07
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2020-06-05
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2020-06-05
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2019-01-02
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2019-01-02
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2025-05-05
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2025-09-18
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-09-18
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2015-11-24
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2015-11-24
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2015-11-24
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-03-11
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-03-11
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2026-01-26
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2026-01-26
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2012-06-12
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2012-06-12
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2022-05-25
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2022-05-25
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2022-05-25
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2022-05-25
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2022-05-25
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-01-25
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2024-01-25
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2023-07-31
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2023-07-31
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2023-07-31
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2023-07-31
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2023-07-31
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2023-07-31
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2022-03-01
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2022-03-01
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2022-03-01
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2022-03-01
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2022-03-01
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2019-11-06
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2019-11-06
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2019-11-06
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-11-06
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2024-05-23
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-10-30
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2011-12-21
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2011-12-21
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-01-09
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2018-01-09
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2018-01-09
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2015-06-09
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2011-12-21
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2011-12-21
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2022-05-25
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2022-05-25
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2022-05-25
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2022-05-25
HTO	Reamer	Orthopedic	Class 1	888.4540	2011-12-21
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2024-05-15
HRW	Dynamometer, Nonpowered	Orthopedic	Class 1	888.1250	2022-10-26
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2013-06-12
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2013-06-12
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2016-12-02
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2016-12-02
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2020-02-19
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2020-02-19
HWK	Trephine	Orthopedic	Class 1	888.4540	2022-12-05
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2017-06-30
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2017-06-30
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2017-06-30
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2017-06-30
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2024-12-05
HXC	Wrench	Orthopedic	Class 1	888.4540	2013-09-19
HWB	Extractor	Orthopedic	Class 1	888.4540	2013-09-23
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-02-25
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2014-11-10
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2014-11-10
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2021-05-06
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2021-05-06
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2021-05-06
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2017-02-13
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2017-02-13
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2017-02-13
HWT	Template	Orthopedic	Class 1	888.4800	2025-08-29
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-09-23
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2013-06-17
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2019-10-23
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2019-10-23
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2019-10-23
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2019-10-23
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-10-23
HWJ	Awl	Orthopedic	Class 1	888.4540	2012-06-18
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2014-06-16
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2014-06-16
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2014-06-16
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2014-06-16
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2014-06-16
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2025-05-29
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2025-05-29
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2025-05-29
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2021-02-16
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2025-08-01
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2020-12-16
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2020-12-16
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2020-12-16

Official Correspondent

Roberto Gabetta

US Agent Details

Sherri Mellingen Email: Sherri.Mellingen@enovis.com Phone: (952) 9136383

Related Public Records

Same Entity

Limacorporate S.p.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3020967480	ProMade PoC Center for Complex Orthopedic Solutions at HSS	Manhattan, NY, US
3008395353	Limacorporate S.p.A.	Calatafimi Segesta (TP) Sicilia, IT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K904879	Endotec, Inc.	BEUCHEL-PAPPAS GLENOID COMPONENT	1991-01-28
K141345	Tornier S.A.S.	AEQUALIS FX2	2014-11-18
K940328	Orthopaedic Innovations, Inc.	PRIME CEMENTED HIP SYSTEM	1995-04-07
K950761	Biomet, Inc.	INDEX ACETABULAT COMPONENT	1995-05-02
K972928	Howmedica, Inc.	KERBOULL CROSS	1997-11-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
Z-0025-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
Z-0026-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600.
Z-0027-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604652.

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3038187464	MIRACLUS ORTHOTECH PRIVATE LIMITED	Ahmedabad Gujarat, IN
3011513267	FLOSPINE LLC	Boca Raton, FL, US
3003882387	B. ALI IMPEX	SIALKOT, Punjab, PK
3002834291	MIAN SHAHID CORP.	MUZAFFAR PUR, SIALKOT Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008021110. Last updated year: 2026. Please use registration number 3008021110 when referencing this establishment in official correspondence.