510(k) K990261
- Device
- PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA)
- Applicant
- PLUS ORTHOPEDICS
- 510(k) number
- K990261
- Product code
- LZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-08-27
- Date received
- 1999-01-27
- 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
- HARTMUT LOCH
- Address
- 3550 General Atomics Ct. Bldg. #15-100 San Diego CA US 92121 92121
FDA Registration Numbers#
- 3008556682
- 3007200272
- 9610612
- 2648920
- 3008868758
- 1822565
- 1057425
- 8043792
- 3014302784
- 3010287737
- 3014833750
- 3015259876
- 3021008900
- 3014644608
- 1835572
- 3006356043
- 1226544
- 3007366790
- 3008262872
- 3002806603
- 3006801265
- 3007051929
- 1000547811
- 3013194153
- 3019807891
- 2244478
- 3005180920
- 1644408
- 3006946276
- 3013302242
- 2134285
- 3012392319
- 3000196378
- 3030412764
- 3010155648
- 3003477135
- 3010065126
- 3005333358
- 9613350
- 3020155054
- 3008395353
- 3009871135
- 3033509898
- 3004493876
- 3006017180
- 3009760038
- 3002807310
- 3010057495
- 3003998208
- 3004153240
- 3003761012
- 3009813841
- 3007391088
- 2246552
- 3007740680
- 3009106092
- 3016438761
- 3017397663
- 3011189525
- 1833986
- 3011295718
- 3043543260
- 3010009693
- 3010375065
- 3009732568
- 1835831
- 3006536454
- 3004188066
- 3002806470
- 3036756245
- 3007120646
- 3031800723
- 3010155661
- 3034676720
- 3011015572
- 3012916784
- 3013791180
- 3005360851
- 1018470
- 3003541440
Source Documents#
Other 510(k) Records For Product Code LZO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262473 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | 2026-10-01 |
| K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2026-09-17 |
| K253948 | Momentum Acetabular Cup System | United Orthopedic Corporation | 2026-09-02 |
| 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 |
Legacy Summary#
summary
FDA Review#
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