The following data is part of a premarket notification filed by Allo Pro Corp. with the FDA for Weber Permalock.
Device ID | K896669 |
510k Number | K896669 |
Device Name: | WEBER PERMALOCK |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | ALLO PRO CORP. POST OFFICE BOX 14159 Clearwater, FL 34279 |
Contact | K Pierpoint |
Correspondent | K Pierpoint ALLO PRO CORP. POST OFFICE BOX 14159 Clearwater, FL 34279 |
Product Code | LZO |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-27 |
Decision Date | 1990-02-06 |