510(k) K122185
- Device
- U-MOTION II ACETABULAR SYSTEM
- Applicant
- UNITED ORTHOPEDIC CORP.
- 510(k) number
- K122185
- Product code
- LZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-02-22
- Date received
- 2012-07-23
- Regulation
- 888.3353
- Classification name
- Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- FANG-YUAN HO
- Address
- # 57, Park Ave. 2, Science Park Hsinchu TW 300 300
FDA Registration Numbers#
- 1834331
- 3005360851
- 3019807891
- 1221053
- 3003541440
- 3004188066
- 3010009693
- 1526534
- 3017397663
- 2032521
- 3004513872
- 3009760038
- 2242737
- 3016438694
- 1720929
- 2245304
- 3002807315
- 3009546990
- 3010536692
- 3014763043
- 2528981
- 8010379
- 9614209
- 1828464
- 3008572101
- 3003998208
- 1722511
- 3011189525
- 3010576282
- 3011170410
- 3006395932
- 3003477135
- 3008544874
- 3000196378
- 3010363503
- 3005323511
- 3009732568
- 1000547811
- 9613350
- 1057425
- 3004371426
- 1822565
- 3004641308
- 3008793310
- 3014833750
- 3004153896
- 9681642
- 3006356043
- 3010041693
- 1218882
- 3008110533
- 3006801265
- 1833920
- 3013176080
- 3015516266
- 3006946276
- 3011683674
- 3003595343
- 9615800
- 1835251
- 3010288357
- 3002806535
- 3014273644
- 8044172
- 3015167917
- 3021386586
- 1827096
- 3007366790
- 3012130008
- 3012319330
- 2249697
- 1721676
- 3009241418
- 3006001176
- 3013791180
- 1649518
- 3008556682
- 1424263
- 3010386387
- 3015398319
Source Documents#
Other 510(k) Records For Product Code LZO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261009 | MobileLink Acetabular Cup System – 40mm ID Inserts (various) | Waldemar Link GmbH & Co. KG | 2026-07-06 |
| K260831 | Z1 Hip System | Zimmer, Inc. | 2026-06-16 |
| K260182 | Avenir® Müller Stem; Avenir Complete™ Hip System | Zimmer, Inc. | 2026-04-27 |
| K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026-03-30 |
| K252401 | implaFit® short stems | Implantcast GmbH | 2026-03-12 |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | Maxx Orthopedics, Inc. | 2026-01-15 |
| K250450 | Coated hip implants | Medacta International S.A. | 2025-09-19 |
| K243021 | Longboard Revision Hip Stem | Signature Orthopaedics Pty, Ltd. | 2025-08-07 |
| K251906 | Z1 Hip System | Zimmer, Inc. | 2025-07-18 |
| K251292 | RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC | 2025-05-23 |
| K243927 | MobileLink Acetabular Cup System - inhouse coatings | Waldemar Link GmbH & Co. KG | 2025-05-16 |
| K250444 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | 2025-05-15 |
| K243043 | Origin™ Cemented Hip Stem | Signature Orthopaedics Pty, Ltd. | 2025-05-02 |
| K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | Zimmer Biomet | 2025-04-18 |
| K250571 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | 2025-03-28 |
Legacy Summary#
summary
FDA Review#
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