510(k) K093644
- Device
- RESTORATION ADM SYSTEM X3 ACETABULAR
- Applicant
- HOWMEDICA OSTEONICS CORP.
- 510(k) number
- K093644
- Product code
- MEH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-12-18
- Date received
- 2009-11-25
- Regulation
- 888.3353
- Classification name
- Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- AVITAL MERL MARGULIES
- Address
- 325 Corporate Dr. Mahwah NJ US 07430 07430
FDA Registration Numbers#
- 3010097171
- 3014302784
- 1226188
- 3006001176
- 3007120646
- 3010314800
- 3010220595
- 3035366890
- 1825034
- 3015207155
- 3010009693
- 9615800
- 1218882
- 3007913880
- 3007051929
- 3005180920
- 3010178296
- 9614209
- 3006356043
- 1722511
- 3006563559
- 3008102042
- 3010206549
- 3038503932
- 3016438761
- 3002807295
- 2242737
- 1043653
- 3005913274
- 2249697
- 3010057495
- 3004153240
- 3021386586
- 3008812251
- 3012916784
- 3005551626
- 1000547811
- 3009760038
- 3013014058
- 3010576282
- 3010287737
- 3013176080
- 3010375065
- 3004748528
- 3008868758
- 3020155054
- 3015542154
- 3010288357
- 9681465
- 3012329926
- 3014170143
- 1000550978
- 3025603301
- 9615674
- 9613369
- 2246552
- 3005562917
- 3008824097
- 1018470
- 3014763043
- 1526534
- 3002807310
- 3002806535
- 3015259876
- 3007353762
- 3009732568
- 1721676
- 3042508254
- 3003387384
- 3002806470
- 1835251
- 3010173425
- 3009888740
- 3010383847
- 1835831
- 3012275107
- 3009173317
- 3010386387
- 1818910
- 3011277306
Source Documents#
Other 510(k) Records For Product Code MEH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250375 | Allure Hip Stem and Intramedullary Plugs | Waldemar Link GmbH & Co. KG | 2025-11-05 |
| K251166 | Mfinity Femoral System | Medacta International S.A. | 2025-06-13 |
| K251052 | Trivicta® Hip Stem | Ortho Development Corp. | 2025-05-22 |
| K242315 | Resolve Modular Revision Hip Stem | United Orthopedic Corporation | 2025-05-01 |
| K243839 | Alteon® HA Femoral Stems | Exactech, Inc. | 2025-03-10 |
| K243162 | World Liner | Signature Orthopaedics Pty, Ltd. | 2024-11-25 |
| K241472 | Icona Hip Stem | Corin U.S.A. Limited | 2024-10-03 |
| K241875 | TheRay Collared and Collarless Femoral Stem | Nextstep Arthropedix | 2024-09-13 |
| K241690 | Logical Liner; World Liner; World Knee Patella | Signature Orthopaedics Pty, Ltd. | 2024-08-01 |
| K233758 | Trivicta™ Hip Stem | Ortho Development Corp. | 2024-03-08 |
| K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional | Depuy Ireland UC | 2024-01-19 |
| K231178 | ACTERA™ hip system | Conformis, Inc. | 2023-05-23 |
| K220495 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | 2023-01-13 |
| K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Stryker | 2022-08-11 |
| K221104 | Actera™ hip system | Conformis, Inc. | 2022-08-04 |
Legacy Summary#
summary
FDA Review#
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