510(k) K042091
- Device
- BIOLOX DELTA CERAMIC HEADS
- Applicant
- BIOMET, INC.
- 510(k) number
- K042091
- Product code
- LZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-03-25
- Date received
- 2004-08-03
- 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
- PATRICIA SANDBORN BERES
- Address
- P.O. Box 587 Warsaw IN US 46581 46581
FDA Registration Numbers#
- 3004142400
- 3006946276
- 3008824097
- 3018052045
- 3006395932
- 3030338875
- 3007366790
- 1531174
- 3012439458
- 3008572101
- 3010178296
- 3008868758
- 1828464
- 8044172
- 1221763
- 3000264985
- 1825034
- 9681642
- 3011277306
- 3014763043
- 1833506
- 1833986
- 1423662
- 3010009693
- 3012275107
- 9613350
- 1450662
- 3003541440
- 3004153240
- 3001278222
- 3009813841
- 3007740680
- 1218882
- 3014252644
- 3013450937
- 3010132111
- 3004638532
- 3013194153
- 1827096
- 3005562917
- 3009106092
- 3006801265
- 2134285
- 3036756245
- 3009241418
- 1643264
- 3009756327
- 3010220595
- 3005333358
- 1722511
- 2244478
- 1822565
- 3006128100
- 1000547811
- 3042508254
- 3013055499
- 1720929
- 3025603301
- 3013413393
- 3036795922
- 3008668801
- 1721676
- 3007334927
- 3011295718
- 1000294921
- 3009888740
- 3027484613
- 3007311878
- 3008262872
- 3002808022
- 3002807314
- 3008544874
- 3012523063
- 3035366890
- 3006536454
- 3010120135
- 3026776
- 3010163695
- 9615674
- 3000196378
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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