510(k) K062997
- Device
- ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS
- Applicant
- BIOMET MANUFACTURING CORP.
- 510(k) number
- K062997
- Product code
- LZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-12-08
- Date received
- 2006-10-02
- 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
- BECKY EARL
- Address
- P.O. Box 587 Warsaw IN US 46581 46581
FDA Registration Numbers#
- 3010155661
- 3030412764
- 3021008900
- 3004188066
- 3013176080
- 1423662
- 3012275107
- 3006946276
- 3004493876
- 3002808022
- 3009871135
- 3009760038
- 3009756327
- 1834379
- 3009475821
- 3009998573
- 3002807315
- 3014170143
- 3008572101
- 3015398319
- 3011461101
- 1833506
- 2242737
- 3005360851
- 3016778562
- 3014302784
- 1526534
- 3017397663
- 3012916784
- 1643264
- 3002806470
- 3012725451
- 3043543260
- 3002806603
- 9613369
- 3018052045
- 9613350
- 3008868758
- 3036795922
- 1226544
- 1530390
- 3002807090
- 3007353762
- 3003541440
- 3010363503
- 3005718816
- 3010375065
- 3008793310
- 3004153240
- 3010041693
- 2245304
- 1645151
- 3019807891
- 3006001176
- 3007200272
- 1835572
- 3016438761
- 1221053
- 3009973505
- 3003477135
- 1057425
- 3014273644
- 3012319330
- 3011295718
- 3010009693
- 1721676
- 1220477
- 1835444
- 2648920
- 2528981
- 3015542154
- 3005061536
- 3009241418
- 3007913880
- 3010039400
- 1221763
- 3010386387
- 3014644608
- 3008812251
Source Documents#
Other 510(k) Records For Product Code LZO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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