510(k) K990183
- Device
- IMPLEX ALUMINA FEMORAL HEAD
- Applicant
- IMPLEX CORP.
- 510(k) number
- K990183
- Product code
- LZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-06-11
- Date received
- 1999-01-20
- 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
- ROBERT POGGIE
- Address
- 80 Commerce Dr. Allendale NJ US 07401 07401
FDA Registration Numbers#
- 3004153240
- 1038671
- 3007353762
- 3011189525
- 3005751028
- 3001278222
- 1649518
- 3003998208
- 3026776
- 3015978338
- 3008824097
- 2249615
- 1825034
- 3013791180
- 3012319330
- 3008572101
- 3012439458
- 3009546990
- 3014302784
- 1644408
- 9616671
- 1226544
- 3010536692
- 1722511
- 3002807090
- 3013014058
- 3004641308
- 2245304
- 3008544874
- 3016438761
- 3004635447
- 3002806470
- 3025603301
- 3033509898
- 3004748528
- 3042508254
- 3009959868
- 3007311878
- 1828288
- 3014833750
- 3034676720
- 3005333358
- 3008668801
- 3012329926
- 1836357
- 3005360851
- 3010155661
- 2134285
- 1721676
- 3005061536
- 1526534
- 1833920
- 3003791208
- 2032521
- 3010097171
- 3013450937
- 2183744
- 3007391088
- 3007913880
- 3006128100
- 3011277306
- 3010468876
- 3014644608
- 3009882462
- 3004638532
- 9681642
- 3010120135
- 3009173317
- 3012119238
- 3012916784
- 3006017180
- 1833986
- 3010041693
- 2648920
- 3009973505
- 3002498892
- 3009760038
- 3008395353
- 3009998573
- 9615674
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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